Details for New Drug Application (NDA): 212160
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NDA 212160 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 212160
| Tradename: | DEXTROAMPHETAMINE SULFATE |
| Applicant: | Winder Labs Llc |
| Ingredient: | dextroamphetamine sulfate |
| Patents: | 0 |
Pharmacology for NDA: 212160
| Physiological Effect | Central Nervous System Stimulation |
Medical Subject Heading (MeSH) Categories for 212160
Suppliers and Packaging for NDA: 212160
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| DEXTROAMPHETAMINE SULFATE | dextroamphetamine sulfate | TABLET;ORAL | 212160 | ANDA | Winder Laboratories LLC | 75826-120 | 75826-120-10 | 100 TABLET in 1 BOTTLE, PLASTIC (75826-120-10) |
| DEXTROAMPHETAMINE SULFATE | dextroamphetamine sulfate | TABLET;ORAL | 212160 | ANDA | Winder Laboratories LLC | 75826-120 | 75826-120-30 | 30 TABLET in 1 BOTTLE, PLASTIC (75826-120-30) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 2.5MG | ||||
| Approval Date: | Jun 7, 2021 | TE: | AA | RLD: | No | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 5MG | ||||
| Approval Date: | Jun 7, 2021 | TE: | AA | RLD: | No | ||||
Profile for product number 003
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 7.5MG | ||||
| Approval Date: | Jun 7, 2021 | TE: | AA | RLD: | No | ||||
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