Details for New Drug Application (NDA): 209954
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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 209954
Tradename: | ALBUTEROL SULFATE |
Applicant: | Lupin |
Ingredient: | albuterol sulfate |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Pharmacology for NDA: 209954
Mechanism of Action | Adrenergic beta2-Agonists |
Suppliers and Packaging for NDA: 209954
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
ALBUTEROL SULFATE | albuterol sulfate | AEROSOL, METERED;INHALATION | 209954 | ANDA | A-S Medication Solutions | 50090-5231 | 50090-5231-0 | 1 CANISTER in 1 CARTON (50090-5231-0) / 200 AEROSOL, METERED in 1 CANISTER |
ALBUTEROL SULFATE | albuterol sulfate | AEROSOL, METERED;INHALATION | 209954 | ANDA | RPK Pharmaceuticals, Inc. | 53002-1554 | 53002-1554-1 | 1 CANISTER in 1 CARTON (53002-1554-1) / 200 AEROSOL, METERED in 1 CANISTER |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | AEROSOL, METERED;INHALATION | Strength | EQ 0.09MG BASE/INH | ||||
Approval Date: | Aug 24, 2020 | TE: | AB2 | RLD: | No |
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