Details for New Drug Application (NDA): 083902
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NDA 083902 describes DEXEDRINE, which is a drug marketed by Glaxosmithkline and Impax Labs Inc and is included in three NDAs. Additional details are available on the DEXEDRINE profile page.
The generic ingredient in DEXEDRINE 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 DEXEDRINE 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 083902
| Tradename: | DEXEDRINE |
| Applicant: | Glaxosmithkline |
| Ingredient: | dextroamphetamine sulfate |
| Patents: | 0 |
Medical Subject Heading (MeSH) Categories for 083902
Profile for product number 001
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | ELIXIR;ORAL | Strength | 5MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | ||||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: | No | |||||
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