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Details for New Drug Application (NDA): 077800

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NDA 077800 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: 077800

Tradename:
LEVALBUTEROL HYDROCHLORIDE
Applicant:
Mylan Speclt
Ingredient:
levalbuterol hydrochloride
Patents:0
Therapeutic Class:Respiratory Tract Agents

Pharmacology for NDA: 077800

Mechanism of ActionAdrenergic beta2-Agonists

Suppliers and Packaging for NDA: 077800

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
LEVALBUTEROL HYDROCHLORIDE
levalbuterol hydrochloride
SOLUTION;INHALATION 077800 ANDA Mylan Pharmaceuticals Inc. 0378-9680 0378-9680-44 2 POUCH in 1 CARTON (0378-9680-44) > 12 VIAL in 1 POUCH (0378-9680-96) > 3 mL in 1 VIAL
LEVALBUTEROL HYDROCHLORIDE
levalbuterol hydrochloride
SOLUTION;INHALATION 077800 ANDA Mylan Pharmaceuticals Inc. 0378-9681 0378-9681-44 2 POUCH in 1 CARTON (0378-9681-44) > 12 VIAL in 1 POUCH (0378-9681-96) > 3 mL in 1 VIAL

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:SOLUTION;INHALATIONStrengthEQ 0.0103% BASE
Approval Date:Mar 15, 2013TE:ANRLD:No

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:SOLUTION;INHALATIONStrengthEQ 0.021% BASE
Approval Date:Mar 15, 2013TE:ANRLD:No

Summary for product number 003

Active Rx/OTC/Discontinued:RXDosage:SOLUTION;INHALATIONStrengthEQ 0.042% BASE
Approval Date:Mar 15, 2013TE:ANRLD:No


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