Details for New Drug Application (NDA): 084051
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NDA 084051 describes DEXTROSTAT, which is a drug marketed by Shire and is included in one NDA. Additional details are available on the DEXTROSTAT profile page.
The generic ingredient in DEXTROSTAT 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 DEXTROSTAT 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 084051
| Tradename: | DEXTROSTAT |
| Applicant: | Shire |
| Ingredient: | dextroamphetamine sulfate |
| Patents: | 0 |
Medical Subject Heading (MeSH) Categories for 084051
Profile for product number 001
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET;ORAL | Strength | 5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | ||||
| Approval Date: | Approved Prior to Jan 1, 1982 | TE: | RLD: | Yes | |||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET;ORAL | Strength | 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | ||||
| Approval Date: | Approved Prior to Jan 1, 1982 | TE: | RLD: | Yes | |||||
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