Details for New Drug Application (NDA): 075584
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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-seven suppliers are listed for this compound. Additional details are available on the bupropion hydrochloride profile page.
Summary for 075584
Tradename: | BUPROPION HYDROCHLORIDE |
Applicant: | Apnar Pharma Lp |
Ingredient: | bupropion hydrochloride |
Patents: | 0 |
Pharmacology for NDA: 075584
Mechanism of Action | Dopamine Uptake Inhibitors Norepinephrine Uptake Inhibitors |
Physiological Effect | Increased Dopamine Activity Increased Norepinephrine Activity |
Suppliers and Packaging for NDA: 075584
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
BUPROPION HYDROCHLORIDE | bupropion hydrochloride | TABLET;ORAL | 075584 | ANDA | Apnar Pharma LP | 24689-119 | 24689-119-01 | 100 TABLET, FILM COATED in 1 BOTTLE (24689-119-01) |
BUPROPION HYDROCHLORIDE | bupropion hydrochloride | TABLET;ORAL | 075584 | ANDA | Apnar Pharma LP | 24689-120 | 24689-120-01 | 100 TABLET, FILM COATED in 1 BOTTLE (24689-120-01) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 75MG | ||||
Approval Date: | Feb 7, 2000 | TE: | AB | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 100MG | ||||
Approval Date: | Feb 7, 2000 | TE: | AB | RLD: | No |
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