Details for New Drug Application (NDA): 076353
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NDA 076353 describes DEXTROAMPHETAMINE SULFATE, which is a drug marketed by Able, Actavis Elizabeth, Dr Reddys Labs Sa, Nesher Pharms, Norvium Bioscience, Specgx Llc, Strides Pharma, Prasco, Tris Pharma Inc, Ani Pharms, Aurolife Pharma Llc, Avanthi Inc, Azurity, Barr, Epic Pharma Llc, Halsey, Lannett, Mast Mm, Novel Labs Inc, Nuvo Pharm, Purepac Pharm, Sandoz, Vitarine, and Winder Labs Llc, and is included in thirty-three NDAs. It is available from fourteen suppliers. Additional details are available on the DEXTROAMPHETAMINE SULFATE profile page.
The generic ingredient in DEXTROAMPHETAMINE SULFATE is dextroamphetamine sulfate. There are eighteen drug master file entries for this compound. Sixteen suppliers are listed for this compound. Additional details are available on the dextroamphetamine sulfate profile page.
The generic ingredient in DEXTROAMPHETAMINE SULFATE is dextroamphetamine sulfate. There are eighteen drug master file entries for this compound. Sixteen suppliers are listed for this compound. Additional details are available on the dextroamphetamine sulfate profile page.
Summary for 076353
| Tradename: | DEXTROAMPHETAMINE SULFATE |
| Applicant: | Specgx Llc |
| Ingredient: | dextroamphetamine sulfate |
| Patents: | 0 |
Pharmacology for NDA: 076353
| Physiological Effect | Central Nervous System Stimulation |
Medical Subject Heading (MeSH) Categories for 076353
Suppliers and Packaging for NDA: 076353
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| DEXTROAMPHETAMINE SULFATE | dextroamphetamine sulfate | CAPSULE, EXTENDED RELEASE;ORAL | 076353 | ANDA | SpecGx LLC | 0406-8960 | 0406-8960-01 | 100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (0406-8960-01) |
| DEXTROAMPHETAMINE SULFATE | dextroamphetamine sulfate | CAPSULE, EXTENDED RELEASE;ORAL | 076353 | ANDA | SpecGx LLC | 0406-8961 | 0406-8961-01 | 100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (0406-8961-01) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE, EXTENDED RELEASE;ORAL | Strength | 5MG | ||||
| Approval Date: | May 6, 2003 | TE: | AB | RLD: | No | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE, EXTENDED RELEASE;ORAL | Strength | 10MG | ||||
| Approval Date: | May 6, 2003 | TE: | AB | RLD: | No | ||||
Profile for product number 003
| Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE, EXTENDED RELEASE;ORAL | Strength | 15MG | ||||
| Approval Date: | May 6, 2003 | TE: | AB | RLD: | No | ||||
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