Details for New Drug Application (NDA): 205401
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NDA 205401 describes DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE, which is a drug marketed by Actavis Elizabeth, Ani Pharms, Ascent Pharms Inc, Aurolife Pharma Llc, Elite Labs Inc, Endo Operations, Granules, Impax Labs, Lannett Co Inc, Nesher Pharms, Rhodes Pharms, Specgx Llc, Sun Pharm Inds Inc, Sun Pharm Industries, Teva, Teva Pharms Usa, Accord Hlthcare, Alkem Labs Ltd, Alvogen, Barr, Cediprof Inc, Epic Pharma Llc, Norvium Bioscience, Nuvo Pharm, Oryza, Sandoz, Teva Pharms, and Zydus Pharms, and is included in thirty-nine NDAs. It is available from twenty-six suppliers. Additional details are available on the DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE profile page.
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.
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 205401
Pharmacology for NDA: 205401
| Physiological Effect | Central Nervous System Stimulation |
Suppliers and Packaging for NDA: 205401
| 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 | CAPSULE, EXTENDED RELEASE;ORAL | 205401 | ANDA | ANI Pharmaceuticals, Inc. | 43975-277 | 43975-277-10 | 100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (43975-277-10) |
| DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE | amphetamine aspartate; amphetamine sulfate; dextroamphetamine saccharate; dextroamphetamine sulfate | CAPSULE, EXTENDED RELEASE;ORAL | 205401 | ANDA | ANI Pharmaceuticals, Inc. | 43975-278 | 43975-278-10 | 100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (43975-278-10) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE, EXTENDED RELEASE;ORAL | Strength | 1.25MG;1.25MG;1.25MG;1.25MG | ||||
| Approval Date: | Jan 22, 2019 | TE: | AB1 | RLD: | No | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE, EXTENDED RELEASE;ORAL | Strength | 2.5MG;2.5MG;2.5MG;2.5MG | ||||
| Approval Date: | Jan 22, 2019 | TE: | AB1 | RLD: | No | ||||
Profile for product number 003
| Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE, EXTENDED RELEASE;ORAL | Strength | 3.75MG;3.75MG;3.75MG;3.75MG | ||||
| Approval Date: | Jan 22, 2019 | TE: | AB1 | RLD: | No | ||||
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