Details for New Drug Application (NDA): 076711
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The generic ingredient in BUPROPION HYDROCHLORIDE is bupropion hydrochloride. There are thirty-eight drug master file entries for this compound. Seventy-six suppliers are listed for this compound. Additional details are available on the bupropion hydrochloride profile page.
Summary for 076711
Tradename: | BUPROPION HYDROCHLORIDE |
Applicant: | Impax Labs |
Ingredient: | bupropion hydrochloride |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Pharmacology for NDA: 076711
Mechanism of Action | Dopamine Uptake Inhibitors Norepinephrine Uptake Inhibitors |
Physiological Effect | Increased Dopamine Activity Increased Norepinephrine Activity |
Suppliers and Packaging for NDA: 076711
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
BUPROPION HYDROCHLORIDE | bupropion hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 076711 | ANDA | Amneal Pharmaceuticals of New York LLC | 0115-5445 | 0115-5445-13 | 60 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (0115-5445-13) |
Profile for product number 001
Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET, EXTENDED RELEASE;ORAL | Strength | 200MG | ||||
Approval Date: | Dec 3, 2004 | TE: | RLD: | No |
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