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Generated: November 24, 2017

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, Teva Pharms, Nephron, Cipla Ltd, Watson Labs Teva, Sandoz Inc, Sun Pharma Global, and Ritedose Corp, and is included in eight NDAs. It is available from thirteen 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-seven drug master file entries for this compound. Sixteen suppliers are listed for this compound. Additional details are available on the albuterol sulfate; ipratropium bromide profile page.

Summary for 076724

Tradename:
1
Applicant:
1
Ingredient:
1
Patents:0
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 0093-6723-73 6 POUCH in 1 CARTON (0093-6723-73) > 5 VIAL, SINGLE-DOSE in 1 POUCH (0093-6723-45) > 3 mL in 1 VIAL, SINGLE-DOSE
ALBUTEROL SULFATE AND IPRATROPIUM BROMIDE
albuterol sulfate; ipratropium bromide
SOLUTION;INHALATION 076724 ANDA Teva Pharmaceuticals USA Inc 0093-6723 0093-6723-74 12 POUCH in 1 CARTON (0093-6723-74) > 5 VIAL, SINGLE-DOSE in 1 POUCH > 3 mL in 1 VIAL, SINGLE-DOSE

Summary 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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