Details for New Drug Application (NDA): 207403
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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 207403
Tradename: | BUPROPION HYDROCHLORIDE |
Applicant: | Micro Labs |
Ingredient: | bupropion hydrochloride |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Pharmacology for NDA: 207403
Mechanism of Action | Dopamine Uptake Inhibitors Norepinephrine Uptake Inhibitors |
Physiological Effect | Increased Dopamine Activity Increased Norepinephrine Activity |
Suppliers and Packaging for NDA: 207403
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
BUPROPION HYDROCHLORIDE | bupropion hydrochloride | TABLET;ORAL | 207403 | ANDA | Micro Labs Limited | 42571-241 | 42571-241-01 | 100 TABLET, FILM COATED in 1 BOTTLE (42571-241-01) |
BUPROPION HYDROCHLORIDE | bupropion hydrochloride | TABLET;ORAL | 207403 | ANDA | Micro Labs Limited | 42571-242 | 42571-242-01 | 100 TABLET, FILM COATED in 1 BOTTLE (42571-242-01) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 75MG | ||||
Approval Date: | Apr 17, 2020 | TE: | AB | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 100MG | ||||
Approval Date: | Apr 17, 2020 | TE: | AB | RLD: | No |
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