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Last Updated: March 5, 2021

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Details for New Drug Application (NDA): 076749

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NDA 076749 describes ALBUTEROL SULFATE AND IPRATROPIUM BROMIDE, which is a drug marketed by Apotex Inc, Aurobindo Pharma Ltd, Cipla, Fosun Pharma, Nephron, Ritedose Corp, Sun Pharm, Teva Pharms, and Watson Labs Teva, and is included in nine NDAs. It is available from eleven 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. Twelve suppliers are listed for this compound. Additional details are available on the albuterol sulfate; ipratropium bromide profile page.
Summary for 076749
Pharmacology for NDA: 076749
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:RXDosage:SOLUTION;INHALATIONStrengthEQ 0.083% BASE;0.017%
Approval Date:Dec 31, 2007TE:ANRLD:No

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