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Last Updated: December 1, 2020

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Details for New Drug Application (NDA): 077772

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NDA 077772 describes ALBUTEROL SULFATE, which is a drug marketed by Cipla, Lupin, Perrigo Pharms Co, Actavis Mid Atlantic, Apotex Inc, Aurobindo Pharma Ltd, Bausch And Lomb, Copley Pharm, Hi Tech Pharma, Landela Pharm, Mylan Speclt, Nephron, Ritedose Corp, Roxane, Sun Pharm, Teva Pharms, Watson Labs, Watson Labs Inc, Wockhardt Eu Operatn, Amneal Pharms, Cosette, Lannett Co Inc, Mova, Quagen, Teva, Vistapharm, Mylan, Am Therap, Amneal Pharms Co, Arise, Dava Pharms Inc, Pliva, Rising, Sun Pharm Industries, Ucb Inc, Virtus Pharm, Warner Chilcott, Yaopharma Co Ltd, Fosun Pharma, and Watson Labs Teva, and is included in seventy-seven NDAs. It is available from thirty-three suppliers. Additional details are available on the ALBUTEROL SULFATE profile page.

The generic ingredient in ALBUTEROL SULFATE is albuterol sulfate; ipratropium bromide. There are thirty-eight drug master file entries for this compound. Twelve suppliers are listed for this compound. Additional details are available on the albuterol sulfate; ipratropium bromide profile page.
Summary for 077772
Tradename:ALBUTEROL SULFATE
Applicant:Watson Labs
Ingredient:albuterol sulfate
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 077772
Mechanism of ActionAdrenergic beta2-Agonists
Suppliers and Packaging for NDA: 077772
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ALBUTEROL SULFATE albuterol sulfate SOLUTION;INHALATION 077772 ANDA Actavis Pharma, Inc. 0591-3467 0591-3467-53 5 POUCH in 1 CARTON (0591-3467-53) > 5 VIAL in 1 POUCH > 3 mL in 1 VIAL
ALBUTEROL SULFATE albuterol sulfate SOLUTION;INHALATION 077772 ANDA Actavis Pharma, Inc. 0591-3468 0591-3468-53 5 POUCH in 1 CARTON (0591-3468-53) > 5 VIAL in 1 POUCH > 3 mL in 1 VIAL

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:SOLUTION;INHALATIONStrengthEQ 0.021% BASE
Approval Date:Sep 25, 2007TE:ANRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:SOLUTION;INHALATIONStrengthEQ 0.042% BASE
Approval Date:Sep 25, 2007TE:ANRLD:No

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Serving leading biopharmaceutical companies globally:

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