Details for New Drug Application (NDA): 208804
✉ 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 208804
Tradename: | ALBUTEROL SULFATE |
Applicant: | Amneal Pharms Co |
Ingredient: | albuterol sulfate |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Pharmacology for NDA: 208804
Mechanism of Action | Adrenergic beta2-Agonists |
Suppliers and Packaging for NDA: 208804
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
ALBUTEROL SULFATE | albuterol sulfate | TABLET;ORAL | 208804 | ANDA | Amneal Pharmaceuticals NY LLC | 69238-1344 | 69238-1344-1 | 100 TABLET in 1 BOTTLE (69238-1344-1) |
ALBUTEROL SULFATE | albuterol sulfate | TABLET;ORAL | 208804 | ANDA | Amneal Pharmaceuticals NY LLC | 69238-1344 | 69238-1344-5 | 500 TABLET in 1 BOTTLE (69238-1344-5) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | EQ 2MG BASE | ||||
Approval Date: | May 21, 2018 | TE: | AB | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | EQ 4MG BASE | ||||
Approval Date: | May 21, 2018 | TE: | AB | RLD: | No |
Complete Access Available with Subscription