Details for New Drug Application (NDA): 206532

NDA 206532 describes ALBUTEROL SULFATE AND IPRATROPIUM BROMIDE, which is a drug marketed by Aiping Pharm Inc, Apotex Inc, Cipla, 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 206532

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

Pharmacology for NDA: 206532

Mechanism of Action

Adrenergic beta2-Agonists Cholinergic Antagonists

Suppliers and Packaging for NDA: 206532

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	206532	ANDA	Aurobindo Pharma Limited	65862-906	65862-906-03	30 POUCH in 1 CARTON (65862-906-03) / 1 VIAL, SINGLE-DOSE in 1 POUCH (65862-906-01) / 3 mL in 1 VIAL, SINGLE-DOSE
ALBUTEROL SULFATE AND IPRATROPIUM BROMIDE	albuterol sulfate; ipratropium bromide	SOLUTION;INHALATION	206532	ANDA	Aurobindo Pharma Limited	65862-906	65862-906-30	6 POUCH in 1 CARTON (65862-906-30) / 5 VIAL, SINGLE-DOSE in 1 POUCH (65862-906-05) / 3 mL in 1 VIAL, SINGLE-DOSE

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	SOLUTION;INHALATION			Strength	EQ 0.083% BASE;0.017%
Approval Date:	Jul 8, 2020	TE:		RLD:	No

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