Details for New Drug Application (NDA): 213583
✉ Email this page to a colleague
NDA 213583 describes AMPHETAMINE SULFATE, which is a drug marketed by Alkem Labs Ltd, Amneal Pharms, Aurolife Pharma Llc, Bionpharma, Dr Reddys Labs Sa, Epic Pharma Llc, Glenmark Pharms Ltd, Granules, Ingenus Pharms Llc, Lannett, Prinston Inc, Rhodes Pharms, Sanaluz, Senores Pharms, Specgx Llc, and Sun Pharm Inds Inc, and is included in sixteen NDAs. It is available from ten suppliers. Additional details are available on the AMPHETAMINE SULFATE profile page.
The generic ingredient in AMPHETAMINE SULFATE is amphetamine sulfate. There is one drug master file entry for this compound. Twelve suppliers are listed for this compound. Additional details are available on the amphetamine sulfate profile page.
The generic ingredient in AMPHETAMINE SULFATE is amphetamine sulfate. There is one drug master file entry for this compound. Twelve suppliers are listed for this compound. Additional details are available on the amphetamine sulfate profile page.
Summary for 213583
| Tradename: | AMPHETAMINE SULFATE |
| Applicant: | Specgx Llc |
| Ingredient: | amphetamine sulfate |
| Patents: | 0 |
Pharmacology for NDA: 213583
| Physiological Effect | Central Nervous System Stimulation |
Suppliers and Packaging for NDA: 213583
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| AMPHETAMINE SULFATE | amphetamine sulfate | TABLET;ORAL | 213583 | ANDA | SpecGx LLC | 0406-1219 | 0406-1219-01 | 100 TABLET in 1 BOTTLE (0406-1219-01) |
| AMPHETAMINE SULFATE | amphetamine sulfate | TABLET;ORAL | 213583 | ANDA | SpecGx LLC | 0406-1220 | 0406-1220-01 | 100 TABLET in 1 BOTTLE (0406-1220-01) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 5MG | ||||
| Approval Date: | Jan 22, 2021 | TE: | AA | RLD: | No | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 10MG | ||||
| Approval Date: | Jan 22, 2021 | TE: | AA | RLD: | No | ||||
Complete Access Available with Subscription
