Details for New Drug Application (NDA): 212619
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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 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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