Details for New Drug Application (NDA): 207085
✉ Email this page to a colleague
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 207085
Tradename: | ALBUTEROL SULFATE |
Applicant: | Sandoz |
Ingredient: | albuterol sulfate |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Pharmacology for NDA: 207085
Mechanism of Action | Adrenergic beta2-Agonists |
Suppliers and Packaging for NDA: 207085
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
ALBUTEROL SULFATE | albuterol sulfate | AEROSOL, METERED;INHALATION | 207085 | ANDA | Hikma Pharmaceuticals USA Inc. | 0054-0742 | 0054-0742-87 | 1 CANISTER in 1 CARTON (0054-0742-87) / 200 AEROSOL, METERED in 1 CANISTER |
ALBUTEROL SULFATE | albuterol sulfate | AEROSOL, METERED;INHALATION | 207085 | ANDA | Asclemed USA, Inc. | 76420-531 | 76420-531-01 | 200 AEROSOL, METERED in 1 CANISTER (76420-531-01) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | AEROSOL, METERED;INHALATION | Strength | EQ 0.09MG BASE/INH | ||||
Approval Date: | Jun 1, 2021 | TE: | AB1 | RLD: | No |
Complete Access Available with Subscription