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Fish and Richardson
Daiichi Sankyo
Harvard Business School

Generated: February 20, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 076724

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NDA 076724 describes ALBUTEROL SULFATE AND IPRATROPIUM BROMIDE, which is a drug marketed by Apotex Inc, Cipla Ltd, Fosun Pharma, Nephron, Ritedose Corp, Sun Pharma Global, Teva Pharms, and Watson Labs Teva, and is included in eight 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. Seventeen suppliers are listed for this compound. Additional details are available on the albuterol sulfate; ipratropium bromide profile page.
Summary for 076724
Applicant:Teva Pharms
Ingredient:albuterol sulfate; ipratropium bromide
Formulation / Manufacturing:see details
Pharmacology for NDA: 076724
Suppliers and Packaging for NDA: 076724
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 076724 ANDA Teva Pharmaceuticals USA Inc 0093-6723 N 0093-6723-73
ALBUTEROL SULFATE AND IPRATROPIUM BROMIDE albuterol sulfate; ipratropium bromide SOLUTION;INHALATION 076724 ANDA Teva Pharmaceuticals USA Inc 0093-6723 N 0093-6723-74

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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