Details for New Drug Application (NDA): 212919
✉ Email this page to a colleague
The generic ingredient in AMPHETAMINE SULFATE is amphetamine sulfate. There are fifty-five drug master file entries for this compound. Thirteen suppliers are listed for this compound. Additional details are available on the amphetamine sulfate profile page.
Summary for 212919
Tradename: | AMPHETAMINE SULFATE |
Applicant: | Bionpharma |
Ingredient: | amphetamine sulfate |
Patents: | 0 |
Pharmacology for NDA: 212919
Physiological Effect | Central Nervous System Stimulation |
Suppliers and Packaging for NDA: 212919
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
AMPHETAMINE SULFATE | amphetamine sulfate | TABLET;ORAL | 212919 | ANDA | Bionpharma Inc. | 69452-227 | 69452-227-20 | 100 TABLET in 1 BOTTLE (69452-227-20) |
AMPHETAMINE SULFATE | amphetamine sulfate | TABLET;ORAL | 212919 | ANDA | Bionpharma Inc. | 69452-228 | 69452-228-20 | 100 TABLET in 1 BOTTLE (69452-228-20) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 5MG | ||||
Approval Date: | Nov 22, 2019 | TE: | AA | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 10MG | ||||
Approval Date: | Nov 22, 2019 | TE: | AA | RLD: | No |
Complete Access Available with Subscription