Details for New Drug Application (NDA): 210293
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The generic ingredient in DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE is amphetamine aspartate; amphetamine sulfate; dextroamphetamine saccharate; dextroamphetamine sulfate. There are fifty-five drug master file entries for this compound. Twenty-eight suppliers are listed for this compound. Additional details are available on the amphetamine aspartate; amphetamine sulfate; dextroamphetamine saccharate; dextroamphetamine sulfate profile page.
Summary for 210293
Pharmacology for NDA: 210293
Physiological Effect | Central Nervous System Stimulation |
Suppliers and Packaging for NDA: 210293
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE | amphetamine aspartate; amphetamine sulfate; dextroamphetamine saccharate; dextroamphetamine sulfate | TABLET;ORAL | 210293 | ANDA | Oryza Pharmaceuticals Inc. | 72516-011 | 72516-011-01 | 100 TABLET in 1 BOTTLE (72516-011-01) |
DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE | amphetamine aspartate; amphetamine sulfate; dextroamphetamine saccharate; dextroamphetamine sulfate | TABLET;ORAL | 210293 | ANDA | Oryza Pharmaceuticals Inc. | 72516-012 | 72516-012-01 | 100 TABLET in 1 BOTTLE (72516-012-01) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 1.25MG;1.25MG;1.25MG;1.25MG | ||||
Approval Date: | Apr 3, 2020 | TE: | AB | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 1.875MG;1.875MG;1.875MG;1.875MG | ||||
Approval Date: | Apr 3, 2020 | TE: | AB | RLD: | No |
Profile for product number 003
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 2.5MG;2.5MG;2.5MG;2.5MG | ||||
Approval Date: | Apr 3, 2020 | TE: | AB | RLD: | No |
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