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Serving leading biopharmaceutical companies globally:

US Department of Justice
Johnson and Johnson
Express Scripts

Generated: December 16, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 200875

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NDA 200875 describes LEVALBUTEROL HYDROCHLORIDE, which is a drug marketed by Aurobindo Pharma Ltd, Cipla Ltd, Impax Labs Inc, Mylan Speciality Lp, Ritedose Corp, Teva Parenteral, and Teva Pharms Usa, and is included in nine NDAs. It is available from ten suppliers. Additional details are available on the LEVALBUTEROL HYDROCHLORIDE profile page.

The generic ingredient in LEVALBUTEROL HYDROCHLORIDE is levalbuterol hydrochloride. There are nine drug master file entries for this compound. Fourteen suppliers are listed for this compound. Additional details are available on the levalbuterol hydrochloride profile page.

Summary for 200875

Therapeutic Class:Respiratory Tract Agents

Pharmacology for NDA: 200875

Mechanism of ActionAdrenergic beta2-Agonists

Suppliers and Packaging for NDA: 200875

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
LEVALBUTEROL HYDROCHLORIDE levalbuterol hydrochloride SOLUTION;INHALATION 200875 ANDA Teva Pharmaceuticals USA Inc 0093-4147 0093-4147-56 30 POUCH in 1 CARTON (0093-4147-56) > 1 VIAL, SINGLE-DOSE in 1 POUCH (0093-4147-19) > .5 mL in 1 VIAL, SINGLE-DOSE

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:SOLUTION;INHALATIONStrengthEQ 0.25% BASE
Approval Date:Sep 11, 2014TE:ANRLD:No

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Serving leading biopharmaceutical companies globally:

Federal Trade Commission
Queensland Health
Chinese Patent Office

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