Zolmitriptan (Zolmitriptan Orally Disintegrating)

Trade Name : Zolmitriptan Orally Disintegrating

Impax Generics

TABLET, ORALLY DISINTEGRATING

Strength 2.5 mg/1

ZOLMITRIPTAN Serotonin 1b Receptor Agonists [MoA],Serotonin 1d Receptor Agonists [MoA],Serotonin-1b and Serotonin-1d Receptor Agonist [EPC]

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GNH India is WHO GDP and ISO 9001 2015 Certified Pharmaceutical Wholesaler/ Supplier/ Exporters/ Importer from India of Zolmitriptan (Zolmitriptan Orally Disintegrating) which is also known as Zolmitriptan Orally Disintegrating and Manufactured by Impax Generics. It is available in strength of 2.5 mg/1 per ml. Read more

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No data

Zolmitriptan tablets and zolmitriptan orally disintegrating tablets are indicated for the acute treatment of migraine with or without aura in adults.
Limitations of Use
Zolmitriptan is a serotonin (5u2011HT) receptor agonist (triptan) indicated for the acute treatment of migraine with or without aura in adults n
Limitations of Use

No data

(2.3n- 8.6)

2.5u00a0mg Tablets:
5u00a0mg Tablets:
2.5u00a0mg Orally Disintegrating Tablets:
5u00a0mg Orally Disintegrating Tablets:

Zolmitriptan tablets and zolmitriptan orally disintegrating tablets are contraindicated in patients with:

No data

Myocardial Ischemia/Infarction, and Prinzmetal Angina
Arrhythmias
Chest/Throat/Neck/Jaw Pain, Tightness, and Pressure
Cerebral Hemorrhage, Subarachnoid Hemorrhage, and Stroke
Gastrointestinal Ischemic Reactions and Peripheral Vasospastic Reactions
Medication Overuse Headache
Serotonin Syndrome
Patients with Phenylketonuria

The following adverse reactions are described elsewhere in other sections of the prescribing information:
Most common adverse reactions (u22655% and >u00a0placebo) were neck/throat/jaw pain/tightness/pressure, dizziness, paresthesia, asthenia, somnolence, warm/cold sensation, nausea, heaviness sensation, and dry mouth ()
To report SUSPECTED ADVERSE REACTIONS, contact Impax Pharmaceuticals at 1-877-994-6729 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch

No data

Pregnancy: Based on animal data, may cause fetal harm n

There is no experience with acute overdose of zolmitriptan tablets or zolmitriptan orally disintegrating tablets. Clinical study subjects who received single 50u00a0mg oral doses of zolmitriptan commonly experienced sedation.
There is no specific antidote to zolmitriptan. In cases of severe intoxication, intensive care procedures are recommended, including establishing and maintaining a patent airway, ensuring adequate oxygenation and ventilation, and monitoring and support of the cardiovascular system.
The elimination halfu2011life of zolmitriptan is 3u00a0hours n n ; therefore, monitor patients after overdose with zolmitriptan tablets or zolmitriptan orally disintegrating tablets for at least 15u00a0hours or until symptoms or signs resolve. It is unknown what effect hemodialysis or peritoneal dialysis has on the plasma concentrations of zolmitriptan.

Zolmitriptan tablets and zolmitriptan orally disintegrating tablets contain zolmitriptan, which is a selective 5u2011hydroxytryptamine (5-HT) receptor agonist. Zolmitriptan is chemically designated as (S)-4-[[3-[2-(dimethylamino)ethyl]-1H-indol-5-yl]methyl]-2-oxazolidinone and has the following chemical structure:
The empirical formula is CHNO, representing a molecular weight of 287.36. Zolmitriptan is a white to almost white powder that is readily soluble in water.
Zolmitriptan tablets are available as 2.5u00a0mg (yellow and functionally-scored) and 5u00a0mg (pink, not scored) film coated tablets for oral administration. The filmu2011coated tablets contain anhydrous lactose NF, microcrystalline cellulose NF, sodium starch glycolate NF, magnesium stearate NF, hydroxypropyl methylcellulose USP, titanium dioxide USP, polyethylene glycol 400 NF, yellow iron oxide NF (2.5u00a0mg tablet), red iron oxide NF (5u00a0mg tablet), and polyethylene glycol 8000 NF.
Zolmitriptan orally disintegrating tablets are available as 2.5u00a0mg and 5u00a0mg white uncoated tablets. The orally disintegrating tablets contain mannitol USP, microcrystalline cellulose NF, crospovidone NF, aspartame NF , sodium bicarbonate USP, citric acid anhydrous USP, colloidal silicon dioxide NF, magnesium stearate NF and orange flavor SN 027512.

No data

Carcinogenesis
Zolmitriptan was administered to mice and rats at doses up to 400 mg/kg/day. Mice were dosed for 85u00a0weeks (males) and 92 weeks (females); rats were dosed for 101u00a0weeks (males) and 86u00a0weeks (females). There was no evidence of drug-induced tumors in mice at plasma exposures (AUC) up to approximately 700u00a0times that in humans at the maximum recommended human dose (MRHD) of 10u00a0mg/day. In rats, there was an increase in the incidence of thyroid follicular cell hyperplasia and thyroid follicular cell adenomas in male rats receiving 400u00a0mg/kg/day. No increase in tumors was observed in rats at 100u00a0mg/kg/day, a dose associated with a plasma AUC approximately 700u00a0times that in humans at the MRHD.
Mutagenesis
Zolmitriptan was positive in an bacterial reverse mutation (Ames) assay and in an chromosomal aberration assay in human lymphocytes. Zolmitriptan was negative in an mammalian gene cell mutation (CHO/HGPRT) assay and in oral mouse micronucleus assays in mouse and rat.
Impairment of Fertility
Studies of male and female rats administered zolmitriptan prior to and during mating and up to implantation showed no impairment of fertility at oral doses up to 400u00a0mg/kg/day. The plasma exposure (AUC) at this dose was approximately 3000u00a0times that in humans at the MRHD.

Zolmitriptan Tablets
The efficacy of zolmitriptan tablets in the acute treatment of migraine headaches was demonstrated in five randomized, double-blind, placebo-controlled studies (Studies 1, 2, 3, 4, and 5), of which two utilized the 1u00a0mg dose, two utilized the 2.5u00a0mg dose and four utilized the 5u00a0mg dose. In Studyu00a01, patients treated their headaches in a clinic setting. In the other studies, patients treated their headaches as outpatients. In Studyu00a04, patients who had previously used sumatriptan were excluded, whereas in the other studies no such exclusion was applied.
Patients enrolled in these 5 studies were predominantly female (82%) and Caucasian (97%) with a mean age of 40u00a0years (range 12u201165). Patients were instructed to treat a moderate to severe headache. Headache response, defined as a reduction in headache severity from moderate or severe pain to mild or no pain, was assessed at 1,u00a02,u00a0and, in most studies, 4u00a0hours after dosing. Associated symptoms such as nausea, photophobia, and phonophobia were also assessed. Maintenance of response was assessed for up to 24u2011hours post-dose. A second dose of zolmitriptan tablets or other medication was allowed 2u2011tou201124 hours after the initial treatment for persistent and recurrent headache. The frequency and time to use of these additional treatments were also recorded. In all studies, the effect of zolmitriptan tablets was compared to placebo in the treatment of a single migraine attack.
In all five studies, the percentage of patients achieving headache response 2u00a0hours after treatment was significantly greater among patients who received zolmitriptan tablets at all doses (except for the 1u00a0mg dose in the smallest study) compared to those who received placebo. In Studies 1u00a0andu00a03, there was a statistically significant greater percentage of patients with headache response at 2u00a0hours in the higher dose groups (2.5u00a0and/or 5u00a0mg) compared to the 1u00a0mg dose group. There were no statistically significant differences between the 2.5 and 5u00a0mg dose groups (or of doses up to 20u00a0mg) for the primary end point of headache response at 2u00a0hours in any study. The results of these controlled clinical studies are summarized in Tableu00a02.
The estimated probability of achieving an initial headache response by 4u00a0hours following treatment in pooled Studies 2,u00a03,u00a0and 5 is depicted in Figureu00a01.
*
For patients with migraine associated photophobia, phonophobia, and nausea at baseline, there was a decreased incidence of these symptoms following administration of zolmitriptan tablets as compared with placebo.
Twou2011tou201124 hours following the initial dose of study treatment, patients were allowed to use additional treatment for pain relief in the form of a second dose of study treatment or other medication. The estimated probability of patients taking a second dose or other medication for migraine over the 24u00a0hours following the initial dose of study treatment is summarized in Figureu00a02.
*In this Kaplan-Meier plot, patients not using additional treatments were censored at 24u00a0hours. The plot includes both patients who had headache response at 2u00a0hours and those who had no response to the initial dose. The studies did not allow taking additional doses of study medication within 2 hours post-dose.
The efficacy of zolmitriptan tablets was unaffected by presence of aura; duration of headache prior to treatment; relationship to menses; gender, age, or weight of the patient; pre-treatment nausea or concomitant use of common migraine prophylactic drugs.
Zolmitriptan Orally Disintegrating Tablets
The efficacy of zolmitriptan orally disintegrating tablets 2.5u00a0mg orally disintegrating tablets was demonstrated in a randomized, placebo-controlled trial (Studyu00a06) that was similar in design to the trials of zolmitriptan tablets. Patients were instructed to treat a moderate to severe headache. Of the 471u00a0patients treated in Study 6, 87% were female and 97% were Caucasian, with a mean age of 41u00a0years (range 18u201162).
At 2u00a0hours postu2011dosing, there was a statistically significant greater percentage of patients treated with zolmitriptan orally disintegrating tablets 2.5u00a0mg with a headache response (reduction in headache severity from moderate or severe pain to mild or no headache) compared to patients treated with placebo (63% vs. 22%). The estimated probability of achieving an initial headache response by 2u00a0hours following treatment with zolmitriptan orally disintegrating tablets is depicted in Figureu00a03.
*In this Kaplan-Meier plot patients taking additional treatment or not achieving headache response prior to 2 hours were censored at 2 hours.
For patients with migraine-associated photophobia, phonophobia and nausea at baseline, there was a decreased incidence of these symptoms following administration of zolmitriptan orally disintegrating tablets as compared to placebo.
Two to 24u00a0hours following the initial dose of study treatment, patients were allowed to use additional treatment in the form of a second dose of study treatment or other medication. The estimated probability of patients taking a second dose or other medication for migraine over the 24 hours following the initial dose of study treatment in Studyu00a06 is summarized in Figureu00a04.
*In this Kaplan-Meier plot, patients not taking additional treatments were censored at 24 hours. The plot includes both patients who had headache response at 2 hours and those who had no response to the initial dose. Taking another dose of study medication was allowed 2 hours post-dose in Study 6. In contrast to studies of zolmitriptan tablets (Studies 1,u00a02,u00a03,u00a04, andu00a05), Studyu00a06 allowed reu2011dosing of zolmitriptan orally disintegrating tablets prior to 4u00a0hours.

2.5u00a0mg Tablets
5u00a0mg Tablets u2013
2.5u00a0mg Orally Disintegrating Tablets -
5u00a0mg Orally Disintegrating Tablets -
Store zolmitriptan tablets and zolmitriptan orally disintegrating tablets at controlled room temperature, 20u201125u00baC (68u201177u00baF) [see USP]. Protect from light and moisture.

Advise the patient to read the FDA-approved patient labeling (Patient Information).
Arrayn- Myocardial Ischemia and/or Infarction, Prinzmetalu2019s Angina, Other Vasospastic Reactions, and Cerebrovascular Events
Inform patients that zolmitriptan tablets and zolmitriptan orally disintegrating tablets may cause serious cardiovascular adverse reactions such as myocardial infarction or stroke, which may result in hospitalization and even death. Although serious cardiovascular reactions can occur without warning symptoms, instruct patients to be alert for the signs and symptoms of chest pain, shortness of breath, weakness, slurring of speech, and instruct them to ask for medical advice when observing any indicative sign or symptoms. Instruct patients to seek medical advice if they have symptoms of other vasospastic reactions .
Arrayn- Medication Overuse Headache
Inform patients that use of drugs to treat acute migraines for 10 or more days per month may lead to an exacerbation of headache, and encourage patients to record headache frequency and drug use (e.g., by keeping a headache diary) .
Arrayn- Serotonin Syndrome
Inform patients about the risk of serotonin syndrome with the use of zolmitriptan tablets and zolmitriptan orally disintegrating tablets or other triptans, particularly during combined use with selective serotonin reuptake inhibitors (SSRIs) or serotonin norepinephrine reuptake inhibitors (SNRIs) .
Arrayn- Pregnancy
Advise patients to notify their healthcare provider if they are pregnant or plan to become pregnant.
Arrayn- Lactation
Advise patients to notify their healthcare provider if they are breastfeeding or plan to breastfeed n n .
Arrayn- Handling of Zolmitriptan Orally Disintegrating Tablets
Inform patients not to break zolmitriptan orally disintegrating tablets. Inform patients that the orally disintegrating tablet is packaged in a blister. Instruct patients not to remove the orally disintegrating tablet from the blister until just prior to dosing. Instruct patients that prior to dosing, peel open the blister pack and place the orally disintegrating tablet on the tongue, where it will dissolve and be swallowed with the saliva .
Arrayn- Patients with Phenylketonuria
Inform patients with phenylketonuria (PKU) that zolmitriptan orally disintegrating tablets contains phenylalanine (a component of aspartame) .

Zolmitriptan
Tablets
Zolmitriptan
Orally Disintegrating Tablets
Please read this information before you start taking zolmitriptan tablets and zolmitriptan orally disintegrating tablets and each time you renew your prescription just in case anything has changed. Remember, this summary does not take the place of discussions with your doctor. You and your doctor should discuss zolmitriptan tablets/ zolmitriptan orally disintegrating tablets when you start taking your medication and at regular checkups.n
What are Zolmitriptan tablets and Zolmitriptan orally disintegrating tablets?
Zolmitriptan tablets and zolmitriptan orally disintegrating tablets are prescription medications used to treat migraine headaches in adults. Zolmitriptan tablets and zolmitriptan orally disintegrating tablets are not for other types of headaches. The safety and efficacy of zolmitriptan tablets and zolmitriptan orally disintegrating tablets in patients under 18 have not been established.
What is a Migraine Headache?
Migraine is an intense, throbbing headache. You may have pain on one or both sides of your head. You may have nausea and vomiting, and be sensitive to light and noise. The pain and symptoms of a migraine headache can be worse than a common headache. Some women get migraines around the time of their menstrual period. Some people have visual symptoms before the headache, such as flashing lights or wavy lines, called an aura.
How do zolmitriptan tablets and zolmitriptan orally disintegrating tablets work?
Treatment with zolmitriptan tablets and zolmitriptan orally disintegrating tablets reduces swelling of blood vessels surrounding the brain. This swelling is associated with the headache pain of a migraine attack. Zolmitriptan tablets and zolmitriptan orally disintegrating tablets block the release of substances from nerve endings that cause more pain and other symptoms like nausea, and sensitivity to light and sound. It is thought that these actions contribute to relief of your symptoms by zolmitriptan tablets and zolmitriptan orally disintegrating tablets.
Tell your doctor about all the medicines you take or plan to take, including prescription and non-prescription medicines, supplements, and herbal remedies.
Tell your doctor if you are sensitive to phenylalanine, which can be found in the artificial sweetener aspartame. Zolmitriptan orally disintegrating tablets contain phenylalanine.
Tell your doctor if you are taking selective serotonin reuptake inhibitors (SSRIs) or serotonin norepinephrine reuptake inhibitors (SNRIs), two types of drugs for depression or other disorders. Common SSRIs are CELEXA (citalopram HBr), LEXAPRO (escitalopram oxalate), PAXIL (paroxetine), PROZAC (fluoxetine), SYMBYAX (olanzapine/fluoxetine), ZOLOFT (sertraline), SARAFEM (fluoxetine) and LUVOX (fluvoxamine). Common SNRIs are CYMBALTA (duloxetine) and EFFEXOR (venlafaxine).
Your doctor will decide if you can take zolmitriptan tablets or zolmitriptan orally disintegrating tablets with your other medicines.
Tell your doctor if you know that you have any of the following: risk factors for heart disease like high cholesterol, diabetes, smoking, obesity (overweight), menopause, or a family history of heart disease or stroke.
Tell your doctor if you are pregnant or plan to become pregnant. It is not known if zolmitriptan tablets and zolmitriptan orally disintegrating tablets will harm your unborn baby.
Tell your doctor if you are breast feeding or plan to breast feed. It is not known if zolmitriptan passes into your breast milk. Talk to your doctor about the best way to feed your baby while using zolmitriptan tablets and zolmitriptan orally disintegrating tablets.
How should I take zolmitriptan tablets and zolmitriptan orally disintegrating tablets?
What are the possible side effects of zolmitriptan tablets and zolmitriptan orally disintegrating tablets?
Zolmitriptan tablets and zolmitriptan orally disintegrating tablets are generally well tolerated. As with any medicine, people taking zolmitriptan tablets or zolmitriptan orally disintegrating tablets may have side effects. The side effects are usually mild and do not last long.
The most common side effects of zolmitriptan tablets and zolmitriptan orally disintegrating tablets are:
In very rare cases, patients taking triptans may experience serious side effects, such as heart attacks, high blood pressure, stroke, or serious allergic reactions. Extremely rarely, patients have died. n n
Some people may have a reaction called serotonin syndrome, which can be life-threatening, when they use zolmitriptan tablets or zolmitriptan orally disintegrating tablets. In particular, this reaction may occur when they use zolmitriptan tablets or zolmitriptan orally disintegrating tablets together with certain types of antidepressants known as SSRIs or SNRIs. Symptoms may include mental changes (hallucinations, agitation, coma), fast heartbeat, changes in blood pressure, high body temperature or sweating, tight muscles, trouble walking, nausea, vomiting, and diarrhea. Call your doctor immediately if you have any of these symptoms after taking zolmitriptan tablets or zolmitriptan orally disintegrating tablets.
This is not a complete list of side effects. Talk to your doctor if you develop any symptoms that concern you.
Array
What to do in case of an overdose?
Call your doctor or poison control center or go to the nearest hospital emergency room.
General advice about zolmitriptan tablets and zolmitriptan orally disintegrating tablets
Medicines are sometimes prescribed for conditions that are not mentioned in patient information leaflets. Do not use zolmitriptan tablets or zolmitriptan orally disintegrating tablets for a condition for which it was not prescribed. Do not give zolmitriptan tablets or zolmitriptan orally disintegrating tablets to other people, even if they have the same symptoms as you. People may be harmed if they take medicines that have not been prescribed for them.
This leaflet summarizes the most important information about zolmitriptan tablets and zolmitriptan orally disintegrating tablets. If you would like more information about zolmitriptan tablets or zolmitriptan orally disintegrating tablets, talk to your doctor. You can ask your doctor or pharmacist for information on zolmitriptan tablets and zolmitriptan orally disintegrating tablets that is written for healthcare professionals. You can also call 1-877-994-6729.
What are the ingredients in zolmitriptan tablets and zolmitriptan orally disintegrating tablets?
Zolmitriptan Tablets
Active ingredient: zolmitriptan
Inactive ingredients: anhydrous lactose NF, microcrystalline cellulose NF, sodium starch glycolate NF, magnesium stearate NF, hydroxypropyl methylcellulose USP, titanium dioxide USP, polyethylene glycol 400u00a0NF, yellow iron oxide NF (2.5u00a0mg tablet), red iron oxide NF (5u00a0mg tablet), and polyethylene glycol 8000u00a0NF
Zolmitriptan Orally Disintegrating Tablets
Active ingredient: zolmitriptan
Inactive ingredients: mannitol USP, microcrystalline cellulose NF, crospovidone NF, aspartame NF, sodium bicarbonate USP, citric acid anhydrous USP, colloidal silicon dioxide NF, magnesium stearate NF and orange flavor SNu00a0027512
Store both zolmitriptan tablets and zolmitriptan orally disintegrating tablets at controlled room temperature, 68u00b0F to 77u00b0F (20u00b0C to 25u00b0C) and away from children. Protect from light and moisture. Discard when expired.
ZOMIG is a registered trademark of the AstraZeneca group of companies. Other brands mentioned are trademarks of their respective owners and are not trademarks of the AstraZeneca group of companies.
u00a9AstraZeneca 2012
Distributed by: Impax Generics
Hayward, CA 94544
Issued 12/2018

NDC 0115u2011u201151
Zolmitriptan Tablets
2.5 mg
Rx only
SIX Tablets
Impax

NDC 0115u2011u201150
Zolmitriptan Tablets
5 mg
Rx only
THREE Tablets
Impax

NDC 0115u2011u201151
Zolmitriptan Orally Disintegrating Tablets
2.5 mg
Rx Only
SIX orally disintegrating tablets
Impax

NDC 0115u2011u201150
Zolmitriptan Orally Disintegrating Tablets
5 mg
Rx only
THREE orally disintegrating tablets
Impax

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Zolmitriptan (Zolmitriptan Orally Disintegrating)

Trade Name : Zolmitriptan Orally Disintegrating

TABLET, ORALLY DISINTEGRATING

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Zolmitriptan (Zolmitriptan Orally Disintegrating)

Trade Name : Zolmitriptan Orally Disintegrating

TABLET, ORALLY DISINTEGRATING

Delivery Process

Product information is meant for

Disclaimer

Trade Marks displayed in compliance with provisions of: Trademark Act, 1999 u/s 30 and 30 (1) of "Fair use"

Packaging and Delivery

About GNH

Similar Products

Desogestrel And Ethinyl Estradiol (Emoquette)

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