Details for New Drug Application (NDA): 209959
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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 209959
Tradename: | ALBUTEROL SULFATE |
Applicant: | Cipla |
Ingredient: | albuterol sulfate |
Patents: | 0 |
Pharmacology for NDA: 209959
Mechanism of Action | Adrenergic beta2-Agonists |
Suppliers and Packaging for NDA: 209959
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
ALBUTEROL SULFATE | albuterol sulfate | AEROSOL, METERED;INHALATION | 209959 | ANDA | A-S Medication Solutions | 50090-5179 | 50090-5179-0 | 1 CANISTER in 1 CARTON (50090-5179-0) / 200 INHALANT in 1 CANISTER |
ALBUTEROL SULFATE | albuterol sulfate | AEROSOL, METERED;INHALATION | 209959 | ANDA | A-S Medication Solutions | 50090-5179 | 50090-5179-1 | 144 CANISTER in 1 CASE (50090-5179-1) / 200 INHALANT 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: | Apr 8, 2020 | TE: | AB1 | RLD: | No |
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