Details for New Drug Application (NDA): 077415
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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-five suppliers are listed for this compound. Additional details are available on the bupropion hydrochloride profile page.
Summary for 077415
Tradename: | BUPROPION HYDROCHLORIDE |
Applicant: | Impax Labs |
Ingredient: | bupropion hydrochloride |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Pharmacology for NDA: 077415
Mechanism of Action | Dopamine Uptake Inhibitors Norepinephrine Uptake Inhibitors |
Physiological Effect | Increased Dopamine Activity Increased Norepinephrine Activity |
Suppliers and Packaging for NDA: 077415
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
BUPROPION HYDROCHLORIDE | bupropion hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 077415 | ANDA | Amneal Pharmaceuticals of New York LLC | 0115-6811 | 0115-6811-02 | 500 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (0115-6811-02) |
BUPROPION HYDROCHLORIDE | bupropion hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 077415 | ANDA | Amneal Pharmaceuticals of New York LLC | 0115-6811 | 0115-6811-08 | 30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (0115-6811-08) |
Profile for product number 001
Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET, EXTENDED RELEASE;ORAL | Strength | 150MG | ||||
Approval Date: | Nov 26, 2008 | TE: | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET, EXTENDED RELEASE;ORAL | Strength | 300MG | ||||
Approval Date: | Dec 15, 2006 | TE: | RLD: | No |
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