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Details for New Drug Application (NDA): 077756

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NDA 077756 describes LEVALBUTEROL HYDROCHLORIDE, which is a drug marketed by Mylan Speclt, Ritedose Corp, Impax Labs Inc, Cipla Ltd, Teva Parenteral, and Teva Pharms Usa, and is included in seven NDAs. It is available from eight 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. Thirteen suppliers are listed for this compound. Additional details are available on the levalbuterol hydrochloride profile page.

Summary for NDA: 077756

Tradename:
LEVALBUTEROL HYDROCHLORIDE
Applicant:
Impax Labs Inc
Ingredient:
levalbuterol hydrochloride
Patents:0
Therapeutic Class:Respiratory Tract Agents

Pharmacology for NDA: 077756

Mechanism of ActionAdrenergic beta2-Agonists

Suppliers and Packaging for NDA: 077756

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
LEVALBUTEROL HYDROCHLORIDE
levalbuterol hydrochloride
SOLUTION;INHALATION 077756 ANDA Actavis Pharma, Inc. 0591-2736 0591-2736-23 2 POUCH in 1 CARTON (0591-2736-23) > 12 VIAL, SINGLE-DOSE in 1 POUCH (0591-2736-39) > 3 mL in 1 VIAL, SINGLE-DOSE
LEVALBUTEROL HYDROCHLORIDE
levalbuterol hydrochloride
SOLUTION;INHALATION 077756 ANDA Actavis Pharma, Inc. 0591-2737 0591-2737-23 2 POUCH in 1 CARTON (0591-2737-23) > 12 VIAL, SINGLE-DOSE in 1 POUCH (0591-2737-39) > 3 mL in 1 VIAL, SINGLE-DOSE

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:SOLUTION;INHALATIONStrengthEQ 0.021% BASE
Approval Date:Apr 9, 2008TE:ANRLD:No

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:SOLUTION;INHALATIONStrengthEQ 0.042% BASE
Approval Date:Apr 9, 2008TE:ANRLD:No

Summary for product number 003

Active Rx/OTC/Discontinued:RXDosage:SOLUTION;INHALATIONStrengthEQ 0.0103% BASE
Approval Date:Apr 9, 2008TE:ANRLD:No


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