Details for New Drug Application (NDA): 083564
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The generic ingredient in DELCOBESE is amphetamine adipate; amphetamine sulfate; dextroamphetamine adipate; dextroamphetamine sulfate. There are fifty-five drug master file entries for this compound. Additional details are available on the amphetamine adipate; amphetamine sulfate; dextroamphetamine adipate; dextroamphetamine sulfate profile page.
Summary for 083564
Tradename: | DELCOBESE |
Applicant: | Teva |
Ingredient: | amphetamine adipate; amphetamine sulfate; dextroamphetamine adipate; dextroamphetamine sulfate |
Patents: | 0 |
Profile for product number 001
Active Rx/OTC/Discontinued: | DISCN | Dosage: | CAPSULE;ORAL | Strength | 1.25MG;1.25MG;1.25MG;1.25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | ||||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 |
Profile for product number 002
Active Rx/OTC/Discontinued: | DISCN | Dosage: | CAPSULE;ORAL | Strength | 2.5MG;2.5MG;2.5MG;2.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | ||||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: | No |
Profile for product number 003
Active Rx/OTC/Discontinued: | DISCN | Dosage: | CAPSULE;ORAL | Strength | 3.75MG;3.75MG;3.75MG;3.75MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | ||||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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