Levalbuterol (Levalbuterol)

Trade Name : Levalbuterol

Teva Pharmaceuticals USA, Inc.

SOLUTION, CONCENTRATE

Strength 1.25 mg/.5mL

LEVALBUTEROL HYDROCHLORIDE Adrenergic beta2-Agonists [MoA],beta2-Adrenergic Agonist [EPC]

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GNH India is WHO GDP and ISO 9001 2015 Certified Pharmaceutical Wholesaler/ Supplier/ Exporters/ Importer from India of Levalbuterol (Levalbuterol) which is also known as Levalbuterol and Manufactured by Teva Pharmaceuticals USA, Inc.. It is available in strength of 1.25 mg/.5mL per ml. Read more

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Levalbuterol inhalation solution (concentrate) is indicated for the treatment or prevention of bronchospasm in adults, adolescents, and children 6 years of age and older with reversible obstructive airway disease.
Levalbuterol inhalation solution (concentrate) is a beta-adrenergic agonist indicated for:

Treatment or prevention of bronchospasm in adults, adolescents, and children 6 years of age and older with reversible obstructive airway disease. ()

Levalbuterol inhalation solution (concentrate) is for oral inhalation only. Dilute with sterile normal saline before administration. Administer by nebulization using a standard jet nebulizer (with a face mask or mouthpiece) connected to an air compressor. Do not exceed recommended dose. For dosages less than 1.25 mg, the non-concentrate (i.e., levalbuterol inhalation solution, 3 mL) formulation must be used.
Children 6 to 11 years old:
Adults and Adolescents n- 12 years old:
Patients 12 years of age and older with more severe asthma or patients who do not respond adequately to a dose of 0.63 mg of levalbuterol inhalation solution may benefit from a dosage of 1.25 mg three times a day.
Patients receiving the highest dose of levalbuterol inhalation solution should be monitored closely for adverse systemic effects, and the risks of such effects should be balanced against the potential for improved efficacy.
The use of levalbuterol inhalation solution can be continued as medically indicated to help control recurring bouts of bronchospasm. During this time, most patients gain optimal benefit from regular use of the inhalation solution.
If a previously effective dosage regimen fails to provide the usual response this may be a marker of destabilization of asthma and requires reevaluation of the patient and the treatment regimen, giving special consideration to the possible need for anti-inflammatory treatment, e.g., corticosteroids.
The drug compatibility (physical and chemical), efficacy, and safety of levalbuterol inhalation solution when mixed with other drugs in a nebulizer have not been established.
The safety and efficacy of levalbuterol inhalation solution have been established in clinical trials when administered using the PARI LC Jetu2122 and PARI LC Plusu2122 nebulizers, and the PARI MasterDura-Neb2000 and Dura-Neb3000 compressors. The safety and efficacy of levalbuterol inhalation solution when administered using other nebulizer systems have not been established.

FOR ORAL INHALATION ONLY ()
Dilute levalbuterol inhalation solution (concentrate) with sterile normal saline before administration by nebulization.
Children 6 to 11 years old:
Adults and Adolescents n- 12 years old:
For use with a standard jet nebulizer (with a face mask or mouthpiece) connected to an air compressor. ()

Levalbuterol Inhalation Solution USP (Concentrate) is supplied in 0.5 mL unit-dose vials containing 1.25 mg/0.5 mL (0.25%) of levalbuterol (as 1.44 mg of levalbuterol hydrochloride) that must be diluted before use. Levalbuterol Inhalation Solution USP (Concentrate) is available in cartons of 30 individually pouched vials.
Inhalation Solution Concentrate (unit-dose vial for nebulization): 1.25 mg/0.5 mL Dilute before use. ()

Levalbuterol inhalation solution is contraindicated in patients with a history of hypersensitivity to levalbuterol or racemic albuterol. Reactions have included urticaria, angioedema, rash, bronchospasm, anaphylaxis, and oropharyngeal edema [see ].

Hypersensitivity to levalbuterol or racemic albuterol. ()

No data

Life-threatening paradoxical bronchospasm may occur. Discontinue levalbuterol inhalation solution immediately and treat with alternative therapy. ()
Need for more doses of levalbuterol inhalation solution than usual may be a sign of deterioration of asthma and requires reevaluation of treatment. ()
Levalbuterol inhalation solution is not a substitute for corticosteroids. ()
Cardiovascular effects may occur. Consider discontinuation of levalbuterol inhalation solution if these effects occur. Use with caution in patients with underlying cardiovascular disorders. ()
Excessive use may be fatal. Do not exceed recommended dose. ()
Immediate hypersensitivity reactions may occur. Discontinue levalbuterol inhalation solution immediately. ()
Hypokalemia and changes in blood glucose may occur. (, )

The following serious adverse reactions are described below and elsewhere in the labeling:
Most common adverse reactions are: palpitations, chest pain, tachycardia, headache, dizziness, tremor and nervousness. ()
To report SUSPECTED ADVERSE REACTIONS, contact u00a0or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

No data

Other short-acting sympathomimetic aerosol bronchodilators and adrenergic drugs: May potentiate effect. ()
Beta-blockers: May block bronchodilatory effects of beta-agonists and produce severe bronchospasm. Patients with asthma should not normally be treated with beta-blockers. ()
Diuretic: May worsen electrocardiographic changes or hypokalemia associated with diuretic may worsen. Consider monitoring potassium levels. ()
Digoxin: May decrease serum digoxin levels. Consider monitoring digoxin levels. ()
Monoamine oxidase inhibitors (MAOs) or tricyclic antidepressants: May potentiate effect of albuterol on the cardiovascular system. ()

No data

The expected symptoms with overdosage are those of excessive beta-adrenergic receptor stimulation and/or occurrence or exaggeration of any of the symptoms listed under , e.g., seizures, angina, hypertension or hypotension, tachycardia with rates up to 200 beats/min., arrhythmias, nervousness, headache, tremor, dry mouth, palpitation, nausea, dizziness, fatigue, malaise, and sleeplessness. Hypokalemia also may occur. As with all sympathomimetic medications, cardiac arrest and even death may be associated with the abuse of levalbuterol inhalation solution. Treatment consists of discontinuation of levalbuterol inhalation solution together with appropriate symptomatic therapy. The judicious use of a cardio selective beta-receptor blocker may be considered, bearing in mind that such medication can produce bronchospasm. There is insufficient evidence to determine if dialysis is beneficial for overdosage of levalbuterol inhalation solution.

Levalbuterol Inhalation Solution USP (Concentrate) is a sterile, clear, colorless, preservative-free solution of the hydrochloride salt of levalbuterol, the (R)-enantiomer of the drug substance racemic albuterol. Levalbuterol hydrochloride, USP is a relatively selective beta-adrenergic receptor agonist [see ]. The chemical name for levalbuterol hydrochloride, USP is (R)-u03b1-[[(1,1-dimethylethyl)amino]methyl]-4-hydroxy-1,3-benzenedimethanol hydrochloride, and its established chemical structure is as follows:
The molecular weight of levalbuterol hydrochloride, USP is 275.8, and its empirical formula is CHNOu2022HCl. It is a white to off-white, crystalline solid, with a melting point of approximately 188u00b0C and is soluble in water and slightly soluble in ethanol.
Levalbuterol hydrochloride, USP is the USAN modified name for (R)-albuterol hydrochloride in the United States.
Levalbuterol Inhalation Solution USP (Concentrate) is supplied in 0.5 mL unit-dose vials that must be diluted with normal saline before administration by nebulization. Each 0.5 mL unit-dose vial contains 1.25 mg of levalbuterol (as 1.44 mg of levalbuterol hydrochloride, USP), 4 mg sodium chloride to adjust tonicity, and 0.055 mg edetate sodium dihydrate, 1 mg of trisodium citrate dihydrate, and sulfuric acid to adjust pH to 4.0 (3.3 to 4.5).

No data

Although there have been no carcinogenesis studies with levalbuterol HCl, racemic albuterol sulfate has been evaluated for its carcinogenic potential. In a 2-year study in Sprague-Dawley rats, dietary administration of racemic albuterol sulfate resulted in a significant dose-related increase in the incidence of benign leiomyomas of the mesovarium at doses of 2 mg/kg/day and greater (approximately 4 times the MRHDID dose of levalbuterol HCl for adults and approximately 5 times the MRHDID dose of levalbuterol HCl for children on a mg/mbasis). In an 18-month study in CD-1 mice and a 22-month study in the golden hamster, dietary administration of racemic albuterol sulfate showed no evidence of tumorigenicity. Dietary doses in CD-1 mice were up to 500 mg/kg/day (approximately 540 times the MRHDID dose of levalbuterol HCl for adults and approximately 630 times the MRHDID dose of levalbuterol HCl for children on a mg/mbasis) and doses in the golden hamster study were up to 50 mg/kg/day (approximately 90 times the MRHDID dose of levalbuterol HCl for adults on a mg/mbasis and approximately 105 times the MRHDID dose of levalbuterol HCl for children on a mg/mbasis).
Levalbuterol HCl was not mutagenic in the Ames test or the CHO/HPRT Mammalian Forward Gene Mutation Assay. Levalbuterol HCl was not clastogenic in the micronucleus test in mouse bone marrow. Racemic albuterol sulfate was not clastogenic in an chromosomal aberration assay in CHO cell cultures.
No fertility studies have been conducted with levalbuterol hydrochloride. Reproduction studies in rats using racemic albuterol sulfate demonstrated no evidence of impaired fertility at oral doses up to 50 mg/kg/day (approximately 108 times the maximum recommended daily inhalation dose of levalbuterol HCl for adults on a mg/mbasis).

Adults and Adolescents u226512 Years Old
The safety and efficacy of levalbuterol inhalation solution were evaluated in a 4-week, multicenter, randomized, double-blind, placebo-controlled, parallel-group study in 362 adult and adolescent patients 12 years of age and older, with mild-to-moderate asthma (mean baseline FEV 60% of predicted). Approximately half of the patients were also receiving inhaled corticosteroids. Patients were randomized to receive levalbuterol 0.63 mg, levalbuterol 1.25 mg, racemic albuterol sulfate 1.25 mg, racemic albuterol sulfate 2.5 mg, or placebo three times a day administered via a PARI LC Plusu2122 nebulizer and a Dura-Nebportable compressor. Racemic albuterol delivered by a chlorofluorocarbon (CFC) metered-dose inhaler (MDI) was used on an as-needed basis as the rescue medication.
Efficacy, as measured by the mean percent change from baseline FEV, was demonstrated for all active treatment regimens compared with placebo on day 1 and day 29. On both day 1 (see Figure 1) and day 29 (see Figure 2), 1.25 mg of levalbuterol demonstrated the largest mean percent change from baseline FEV compared with the other active treatments. A dose of 0.63 mg of levalbuterol and 2.5 mg of racemic albuterol sulfate produced a clinically comparable mean percent change from baseline FEV on both day 1 and day 29.
Figure 1: Mean Percent Change from Baseline FEV on Day 1, Adults and Adolescents u226512 years old
Figure 2: Mean Percent Change from Baseline FEV on Day 29, Adults and Adolescents u226512 years old
The mean time to onset of a 15% increase in FEV over baseline for levalbuterol at doses of 0.63 mg and 1.25 mg was approximately 17 minutes and 10 minutes, respectively, and the mean time to peak effect for both doses was approximately 1.5 hours after 4 weeks of treatment. The mean duration of effect, as measured by a >15% increase from baseline FEV, was approximately 5 hours after administration of 0.63 mg of levalbuterol and approximately 6 hours after administration of 1.25 mg of levalbuterol after 4 weeks of treatment. In some patients, the duration of effect was as long as 8 hours.
Children 6 to 11 Years Old
A multicenter, randomized, double-blind, placebo- and active-controlled study was conducted in children with mild-to-moderate asthma (mean baseline FEV 73% of predicted) (n = 316). Following a 1-week placebo run-in, subjects were randomized to levalbuterol (0.31 or 0.63 mg), racemic albuterol (1.25 or 2.5 mg), or placebo, which were delivered three times a day for 3 weeks using a PARI LC Plusu2122 nebulizer and a Dura-Neb3000 compressor.
Efficacy, as measured by mean peak percent change from baseline FEV, was demonstrated for all active treatment regimens compared with placebo on day 1 and day 21. Time profile FEV curves for day 1 and day 21 are shown in Figure 3 and Figure 4, respectively. The onset of effect (time to a 15% increase in FEV over test-day baseline) and duration of effect (maintenance of a >15% increase in FEV over test-day baseline) of levalbuterol were clinically comparable to those of racemic albuterol.
Figure 3: Mean Percent Change from Baseline FEV on Day 1, Children 6 to 11 Years of Age
Figure 4: Mean Percent Change from Baseline FEV on Day 21, Children 6 to 11 Years of Age

Levalbuterol Inhalation Solution USP (Concentrate) is supplied in 0.5 mL unit-dose, low-density polyethylene (LDPE) vials, and is a clear, colorless, sterile, preservative-free, aqueous solution. Each vial contains 1.25 mg/0.5 mL (0.25%) of levalbuterol (as 1.44 mg of levalbuterol hydrochloride, USP) and is available in cartons of 30 (NDC 0093-4147-56) individually pouched vials.
Store Levalbuterol Inhalation Solution USP (Concentrate) in the protective foil pouch at 20u00b0 to 25u00b0C (68u00b0 to 77u00b0F) [see USP Controlled Room Temperature]. Protect from light and excessive heat. Open the foil pouch just prior to administration. Once the foil pouch is opened, the contents of the vial should be used immediately. Discard any vial if the solution is not colorless.
Dilute Levalbuterol Inhalation Solution USP (Concentrate) with sterile normal saline before administration by nebulization.
To report SUSPECTED ADVERSE REACTIONS, contact Teva Pharmaceuticals USA, Inc. at 1-888-838-2872 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
For more information, call Teva Pharmaceuticals USA, Inc. at 1-888-838-2872.
All brand names listed are the registered trademarks of their respective owners and are not trademarks of Teva Pharmaceuticals USA.

See FDA-approved patient labeling (Patient Information and Instructions for Using Levalbuterol Inhalation Solution (Concentrate)).
Patients should be given the following information:
Hypersensitivity
Query patients about previously experienced hypersensitivity to levalbuterol or racemic albuterol and counsel patients to report any hypersensitivity reactions to their physician.
Frequency of Use
Inform patients not to increase the dose or use levalbuterol inhalation solution more frequently than recommended without consulting their physician. If patients find that treatment with levalbuterol inhalation solution becomes less effective for symptomatic relief, symptoms become worse, or they need to use the product more frequently than usual, they should seek medical attention immediately.
Paradoxical Bronchospasm
Inform patients that levalbuterol inhalation solution can produce paradoxical bronchospasm. Instruct patients to discontinue levalbuterol inhalation solution if paradoxical bronchospasm occurs.
Concomitant Drug Use
Inform patients using levalbuterol inhalation solution, that other inhaled drugs and asthma medications should be taken only as directed by their physician.
Common Adverse Reactions
Advise patients of the common adverse reactions of treatment with levalbuterol inhalation solution including palpitations, chest pain, fast heart rate, headache, dizziness, tremor and nervousness.
Pregnancy
Advise patients who are pregnant or nursing to contact their physician about the use of levalbuterol inhalation solution.
General Information on Storage and Use
Advise patients to dilute levalbuterol inhalation solution (concentrate) with sterile normal saline before administration by nebulization.
Advise patients how to store levalbuterol inhalation solution (concentrate). Store in the foil pouch between 20u00b0C to 25u00b0C (68u00b0F to 77u00b0F) protected from light and excessive heat. Do not use after the expiration date stamped on the container. Open the foil pouch just prior to administration. Once the foil pouch is opened, use the contents of the vial immediately. Discard any vial if the solution is not colorless.
Advise patients not to mix levalbuterol inhalation solution with other drugs in a nebulizer.
Manufactured In England By:n n Runcorn, Cheshire WA7 3FA England
Manufactured For:n n North Wales, PA 19454
Rev. D 1/2019
PHARMACIST u2014 DETACH HERE AND GIVE LEAFLET TO PATIENT

Levalbuterol (leh-val-BYOO-ter-all)
Inhalation Solution (Concentrate), 0.25% (1.25 mg/0.5 mL) Unit-Dose Vials
Read this Patient Information before you start to use levalbuterol inhalation solution (concentrate) and each time you get a refill. There may be new information. This information does not take the place of talking with your doctor about your medical condition or your treatment.
What is levalbuterol inhalation solution (concentrate)?
Levalbuterol inhalation solution (concentrate) is an inhaled prescription medicine used for the treatment or prevention of bronchospasm in people 6 years of age and older.
Levalbuterol inhalation solution (concentrate) has not been shown to be safe and effective in children younger than 6 years of age.
Levalbuterol inhalation solution (concentrate) is supplied in 0.5 mL unit-dose vials that require dilution with sterile normal saline before use.
Who should not use levalbuterol inhalation solution (concentrate)?
Do not use levalbuterol inhalation solution (concentrate) if you
What should I tell my doctor before using levalbuterol inhalation solution (concentrate)?
Before you use levalbuterol inhalation solution (concentrate), tell your doctor if you have:
Tell your doctor about all the medicines you take
Especially tell your doctor if you take:
Ask your doctor if you are not sure if any of your medicines are the kinds listed above.
Know the medicines you take. Keep a list of them and show it to your doctor and pharmacist when you get a new medicine.
How should I use levalbuterol inhalation solution (concentrate)?
What are the possible side effects of levalbuterol inhalation solution (concentrate)?
Levalbuterol inhalation solution (concentrate) can cause serious side effects including:
Call your doctor or go to the nearest hospital emergency room right away if you have any of the serious side effects listed above or if you have worsening lung symptoms.
The most common side effects of levalbuterol inhalation solution (concentrate) include:
Tell your doctor if you have any side effects that bother you or that do not go away.
These are not all the possible side effects of levalbuterol inhalation solution (concentrate). For more information, ask your doctor or pharmacist.
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
How should I store levalbuterol inhalation solution (concentrate)?
Keep levalbuterol inhalation solution (concentrate) and all medicines out of the reach of children.
General information about the safe and effective use of levalbuterol inhalation solution (concentrate).
Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not use levalbuterol inhalation solution (concentrate) for a condition for which it was not prescribed. Do not give levalbuterol inhalation solution (concentrate) to other people, even if they have the same symptoms that you have. It may harm them.
This Patient Information leaflet summarizes the most important information about levalbuterol inhalation solution (concentrate). If you would like more information, talk with your doctor. You can ask your pharmacist or doctor for information about levalbuterol inhalation solution (concentrate) that is written for health professionals.
To report SUSPECTED ADVERSE REACTIONS, contact Teva Pharmaceuticals USA, Inc. at 1-888-838-2872 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
For more information, call Teva Pharmaceuticals USA, Inc. at 1-888-838-2872.
What are the ingredients in levalbuterol inhalation solution (concentrate)?
Active ingredient: levalbuterol hydrochloride
Inactive ingredients: sodium chloride, edetate sodium dihydrate, trisodium citrate dihydrate, and sulfuric acid to adjust pH.
Levalbuterol inhalation solution (concentrate) vial (see Figure A):
Using your Levalbuterol:
Read the following steps before
You will need to mix your levalbuterol inhalation solution (concentrate) with sterile normal saline before you give your dose. n- not
Step 1. n- See Figure B
Step 2. n- See Figure C
Step 3. n- See Figure C
Step 4. n- See Figure D
Step 5. n- See Figure E
Step 6. n- See Figure F.1n- See Figure F.2
Step 7. n- See Figure G
Step 8. n- See Figure H.1n- See Figure H.2
Step 9.
Step 10.
This Patient Information and Instructions for Use have been approved by the U.S. Food and Drug Administration.
To report SUSPECTED ADVERSE REACTIONS, contact Teva Pharmaceuticals USA, Inc. at 1-888-838-2872 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
For more information, call Teva Pharmaceuticals USA, Inc. at 1-888-838-2872.
Manufactured In England By:n n Runcorn, Cheshire WA7 3FA England
Manufactured For:n n North Wales, PA 19454
Rev. C 1/2019

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Levalbuterol (Levalbuterol)

Trade Name : Levalbuterol

SOLUTION, CONCENTRATE

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"

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Levalbuterol (Levalbuterol)

Trade Name : Levalbuterol

SOLUTION, CONCENTRATE

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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