Details for New Drug Application (NDA): 074454
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The generic ingredient in ALBUTEROL SULFATE 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 074454
Tradename: | ALBUTEROL SULFATE |
Applicant: | Cosette |
Ingredient: | albuterol sulfate |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Pharmacology for NDA: 074454
Mechanism of Action | Adrenergic beta2-Agonists |
Suppliers and Packaging for NDA: 074454
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
ALBUTEROL SULFATE | albuterol sulfate | SYRUP;ORAL | 074454 | ANDA | Actavis Pharma, Inc. | 0472-0825 | 0472-0825-04 | 118 mL in 1 BOTTLE (0472-0825-04) |
ALBUTEROL SULFATE | albuterol sulfate | SYRUP;ORAL | 074454 | ANDA | Actavis Pharma, Inc. | 0472-0825 | 0472-0825-16 | 473 mL in 1 BOTTLE (0472-0825-16) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | SYRUP;ORAL | Strength | EQ 2MG BASE/5ML | ||||
Approval Date: | Sep 25, 1995 | TE: | AA | RLD: | No |
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