Details for New Drug Application (NDA): 017078
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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 |
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 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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