Details for New Drug Application (NDA): 208606
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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 208606
Tradename: | BUPROPION HYDROCHLORIDE |
Applicant: | Cadila Pharms Ltd |
Ingredient: | bupropion hydrochloride |
Patents: | 0 |
Pharmacology for NDA: 208606
Mechanism of Action | Dopamine Uptake Inhibitors Norepinephrine Uptake Inhibitors |
Physiological Effect | Increased Dopamine Activity Increased Norepinephrine Activity |
Suppliers and Packaging for NDA: 208606
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
BUPROPION HYDROCHLORIDE | bupropion hydrochloride | TABLET;ORAL | 208606 | ANDA | Cadila Pharmaceuticals Limited | 71209-052 | 71209-052-05 | 100 TABLET, FILM COATED in 1 BOTTLE (71209-052-05) |
BUPROPION HYDROCHLORIDE | bupropion hydrochloride | TABLET;ORAL | 208606 | ANDA | Cadila Pharmaceuticals Limited | 71209-052 | 71209-052-11 | 1000 TABLET, FILM COATED in 1 BOTTLE (71209-052-11) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 75MG | ||||
Approval Date: | Jan 16, 2020 | TE: | AB | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 100MG | ||||
Approval Date: | Jan 16, 2020 | TE: | AB | RLD: | No |
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