Details for New Drug Application (NDA): 017078
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NDA 017078 describes DEXEDRINE SPANSULE, which is a drug marketed by Impax Labs Inc and is included in one NDA. It is available from two suppliers. Additional details are available on the DEXEDRINE SPANSULE profile page.
The generic ingredient in DEXEDRINE SPANSULE 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 SPANSULE 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 017078
| Tradename: | DEXEDRINE SPANSULE |
| Applicant: | Impax Labs Inc |
| Ingredient: | dextroamphetamine sulfate |
| Patents: | 0 |
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 SPANSULE | 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 SPANSULE | 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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