Details for New Drug Application (NDA): 202304
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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 202304
Tradename: | BUPROPION HYDROCHLORIDE |
Applicant: | Prinston Inc |
Ingredient: | bupropion hydrochloride |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Pharmacology for NDA: 202304
Mechanism of Action | Dopamine Uptake Inhibitors Norepinephrine Uptake Inhibitors |
Physiological Effect | Increased Dopamine Activity Increased Norepinephrine Activity |
Suppliers and Packaging for NDA: 202304
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
BUPROPION HYDROCHLORIDE | bupropion hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 202304 | ANDA | NCS HealthCare of KY, LLC dba Vangard Labs | 0615-8262 | 0615-8262-39 | 30 TABLET, EXTENDED RELEASE in 1 BLISTER PACK (0615-8262-39) |
BUPROPION HYDROCHLORIDE | bupropion hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 202304 | ANDA | Solco Healthcare US LLC | 43547-288 | 43547-288-06 | 60 TABLET, EXTENDED RELEASE in 1 BOTTLE (43547-288-06) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET, EXTENDED RELEASE;ORAL | Strength | 100MG | ||||
Approval Date: | May 26, 2015 | TE: | AB1 | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET, EXTENDED RELEASE;ORAL | Strength | 150MG | ||||
Approval Date: | May 26, 2015 | TE: | AB1 | RLD: | No |
Profile for product number 003
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET, EXTENDED RELEASE;ORAL | Strength | 200MG | ||||
Approval Date: | May 26, 2015 | TE: | AB1 | RLD: | No |
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