Details for New Drug Application (NDA): 212619
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NDA 212619 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 212619
| Tradename: | AMPHETAMINE SULFATE |
| Applicant: | Granules |
| Ingredient: | amphetamine sulfate |
| Patents: | 0 |
Pharmacology for NDA: 212619
| Physiological Effect | Central Nervous System Stimulation |
Suppliers and Packaging for NDA: 212619
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| AMPHETAMINE SULFATE | amphetamine sulfate | TABLET;ORAL | 212619 | ANDA | Granules Pharmaceuticals Inc. | 70010-040 | 70010-040-01 | 100 TABLET in 1 BOTTLE (70010-040-01) |
| AMPHETAMINE SULFATE | amphetamine sulfate | TABLET;ORAL | 212619 | ANDA | Granules Pharmaceuticals Inc. | 70010-041 | 70010-041-01 | 100 TABLET in 1 BOTTLE (70010-041-01) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 5MG | ||||
| Approval Date: | Aug 5, 2019 | TE: | AA | RLD: | No | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 10MG | ||||
| Approval Date: | Aug 5, 2019 | TE: | AA | RLD: | No | ||||
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