Details for New Drug Application (NDA): 076749

NDA 076749 describes ALBUTEROL SULFATE AND IPRATROPIUM BROMIDE, which is a drug marketed by Apotex Inc, Cipla, Fosun Pharma, Luoxin Aurovitas, Nephron, Ritedose Corp, Sun Pharm, Teva Pharms, and Watson Labs Teva, and is included in nine NDAs. It is available from fourteen suppliers. Additional details are available on the ALBUTEROL SULFATE AND IPRATROPIUM BROMIDE profile page.

The generic ingredient in ALBUTEROL SULFATE AND IPRATROPIUM BROMIDE is albuterol sulfate; ipratropium bromide. There are thirty-eight drug master file entries for this compound. Fifteen suppliers are listed for this compound. Additional details are available on the albuterol sulfate; ipratropium bromide profile page.

Summary for 076749

Tradename:	ALBUTEROL SULFATE AND IPRATROPIUM BROMIDE
Applicant:	Nephron
Ingredient:	albuterol sulfate; ipratropium bromide
Patents:	0

Pharmacology for NDA: 076749

Mechanism of Action

Adrenergic beta2-Agonists Cholinergic Antagonists

Suppliers and Packaging for NDA: 076749

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
ALBUTEROL SULFATE AND IPRATROPIUM BROMIDE	albuterol sulfate; ipratropium bromide	SOLUTION;INHALATION	076749	ANDA	Nephron Pharmaceuticals Corporation	0487-0201	0487-0201-01	30 POUCH in 1 CARTON (0487-0201-01) / 1 VIAL, SINGLE-USE in 1 POUCH / 3 mL in 1 VIAL, SINGLE-USE
ALBUTEROL SULFATE AND IPRATROPIUM BROMIDE	albuterol sulfate; ipratropium bromide	SOLUTION;INHALATION	076749	ANDA	Nephron Pharmaceuticals Corporation	0487-0201	0487-0201-02	30 POUCH in 1 CARTON (0487-0201-02) / 1 VIAL, SINGLE-USE in 1 POUCH / 3 mL in 1 VIAL, SINGLE-USE

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	SOLUTION;INHALATION			Strength	EQ 0.083% BASE;0.017%
Approval Date:	Dec 31, 2007	TE:	AN	RLD:	No

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