Details for New Drug Application (NDA): 017078
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NDA 017078 describes DEXEDRINE, which is a drug marketed by Impax Labs Inc and Glaxosmithkline and is included in three NDAs. It is available from two suppliers. 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. Seventeen 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. Seventeen suppliers are listed for this compound. Additional details are available on the dextroamphetamine sulfate profile page.
Summary for 017078
| Tradename: | DEXEDRINE |
| Applicant: | Impax Labs Inc |
| Ingredient: | dextroamphetamine sulfate |
| Patents: | 0 |
| Formulation / Manufacturing: | see details |
Pharmacology for NDA: 017078
| Physiological Effect | Central Nervous System Stimulation |
Medical Subject Heading (MeSH) Categories for 017078
Suppliers and Packaging for NDA: 017078
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| DEXEDRINE | dextroamphetamine sulfate | CAPSULE, EXTENDED RELEASE;ORAL | 017078 | NDA AUTHORIZED GENERIC | Amneal Pharmaceuticals of New York LLC | 0115-9927 | 0115-9927-10 | 90 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (0115-9927-10) |
| DEXEDRINE | dextroamphetamine sulfate | CAPSULE, EXTENDED RELEASE;ORAL | 017078 | NDA AUTHORIZED GENERIC | Amneal Pharmaceuticals of New York LLC | 0115-9928 | 0115-9928-10 | 90 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (0115-9928-10) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE, EXTENDED RELEASE;ORAL | Strength | 5MG | ||||
| Approval Date: | Approved Prior to Jan 1, 1982 | TE: | AB | RLD: | Yes | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE, EXTENDED RELEASE;ORAL | Strength | 10MG | ||||
| Approval Date: | Approved Prior to Jan 1, 1982 | TE: | AB | RLD: | Yes | ||||
Profile for product number 003
| Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE, EXTENDED RELEASE;ORAL | Strength | 15MG | ||||
| Approval Date: | Approved Prior to Jan 1, 1982 | TE: | AB | RLD: | Yes | ||||
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