Details for New Drug Application (NDA): 203013
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NDA 203013 describes BUPROPION HYDROCHLORIDE, which is a drug marketed by Accord Hlthcare, Actavis Labs Fl Inc, Anbison Lab, Annora Pharma, Aurobindo Pharma Usa, Endo Operations, Epic Pharma Llc, Granules, Graviti Pharms, Impax Labs, Invagen Pharms, Jubilant Generics, Lupin Ltd, Prinston Inc, Rising, Sandoz, Sciegen Pharms Inc, Sinotherapeutics Inc, Sun Pharm, Torrent, Twi Pharms, Watson Labs Inc, Wockhardt Ltd, Yichang Humanwell, Zhejiang Jutai Pharm, Zydus Pharms, Alembic, Apnar Pharma Lp, Apotex Inc, Cadila Pharms Ltd, Heritage Pharma, Invatech, and Micro Labs, and is included in fifty-nine NDAs. It is available from seventy-two suppliers. Additional details are available on the BUPROPION HYDROCHLORIDE profile page.
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.
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 203013
| Tradename: | BUPROPION HYDROCHLORIDE |
| Applicant: | Alembic |
| Ingredient: | bupropion hydrochloride |
| Patents: | 0 |
Pharmacology for NDA: 203013
| Mechanism of Action | Dopamine Uptake Inhibitors Norepinephrine Uptake Inhibitors |
| Physiological Effect | Increased Dopamine Activity Increased Norepinephrine Activity |
Suppliers and Packaging for NDA: 203013
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| BUPROPION HYDROCHLORIDE | bupropion hydrochloride | TABLET;ORAL | 203013 | ANDA | Alembic Pharmaceuticals Limited | 46708-118 | 46708-118-31 | 100 TABLET, FILM COATED in 1 BOTTLE (46708-118-31) |
| BUPROPION HYDROCHLORIDE | bupropion hydrochloride | TABLET;ORAL | 203013 | ANDA | Alembic Pharmaceuticals Limited | 46708-118 | 46708-118-91 | 1000 TABLET, FILM COATED in 1 BOTTLE (46708-118-91) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 75MG | ||||
| Approval Date: | Jun 8, 2018 | TE: | AB | RLD: | No | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 100MG | ||||
| Approval Date: | Jun 8, 2018 | TE: | AB | RLD: | No | ||||
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