Details for New Drug Application (NDA): 207479
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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 207479
Tradename: | BUPROPION HYDROCHLORIDE |
Applicant: | Sciegen Pharms Inc |
Ingredient: | bupropion hydrochloride |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Pharmacology for NDA: 207479
Mechanism of Action | Dopamine Uptake Inhibitors Norepinephrine Uptake Inhibitors |
Physiological Effect | Increased Dopamine Activity Increased Norepinephrine Activity |
Suppliers and Packaging for NDA: 207479
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
BUPROPION HYDROCHLORIDE | bupropion hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 207479 | ANDA | Dr Reddys Laboratories Inc | 43598-655 | 43598-655-05 | 500 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (43598-655-05) |
BUPROPION HYDROCHLORIDE | bupropion hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 207479 | ANDA | Dr Reddys Laboratories Inc | 43598-655 | 43598-655-30 | 30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (43598-655-30) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET, EXTENDED RELEASE;ORAL | Strength | 150MG | ||||
Approval Date: | Apr 12, 2017 | TE: | AB3 | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET, EXTENDED RELEASE;ORAL | Strength | 300MG | ||||
Approval Date: | Apr 12, 2017 | TE: | AB3 | RLD: | No |
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