Details for New Drug Application (NDA): 079094
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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 079094
Tradename: | BUPROPION HYDROCHLORIDE |
Applicant: | Actavis Labs Fl Inc |
Ingredient: | bupropion hydrochloride |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Pharmacology for NDA: 079094
Mechanism of Action | Dopamine Uptake Inhibitors Norepinephrine Uptake Inhibitors |
Physiological Effect | Increased Dopamine Activity Increased Norepinephrine Activity |
Suppliers and Packaging for NDA: 079094
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
BUPROPION HYDROCHLORIDE | bupropion hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 079094 | ANDA | Actavis Pharma, Inc. | 0591-3543 | 0591-3543-60 | 60 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (0591-3543-60) |
BUPROPION HYDROCHLORIDE | bupropion hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 079094 | ANDA | Actavis Pharma, Inc. | 0591-3543 | 0591-3543-76 | 1 BOTTLE, PLASTIC in 1 CARTON (0591-3543-76) / 60 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET, EXTENDED RELEASE;ORAL | Strength | 150MG | ||||
Approval Date: | Mar 24, 2009 | TE: | AB2 | RLD: | No |
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