Details for New Drug Application (NDA): 214277
✉ Email this page to a colleague
NDA 214277 describes CARBAMAZEPINE, which is a drug marketed by Apotex Inc, Nostrum Labs Inc, Taro, Teva Pharms, Chartwell Rx, Novitium Pharma, Jubilant Cadista, Taro Pharm Inds, Torrent Pharms, Ajanta Pharma Ltd, Amneal Pharms, Anbison Lab, Apotex, Cspc Ouyi, Epic Pharma Llc, Novast Labs, Umedica, Unique Pharm, Zhejiang Jiuzhou, Zydus Pharms, Actavis Elizabeth, Bionpharma, Inwood Labs, Pliva, Rk Pharma, Unichem, Usl Pharma, and Warner Chilcott, and is included in thirty-four NDAs. It is available from thirty-eight suppliers. Additional details are available on the CARBAMAZEPINE profile page.
The generic ingredient in CARBAMAZEPINE is carbamazepine. There are twenty-seven drug master file entries for this compound. Forty-six suppliers are listed for this compound. Additional details are available on the carbamazepine profile page.
The generic ingredient in CARBAMAZEPINE is carbamazepine. There are twenty-seven drug master file entries for this compound. Forty-six suppliers are listed for this compound. Additional details are available on the carbamazepine profile page.
Summary for 214277
| Tradename: | CARBAMAZEPINE |
| Applicant: | Novitium Pharma |
| Ingredient: | carbamazepine |
| Patents: | 0 |
Suppliers and Packaging for NDA: 214277
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| CARBAMAZEPINE | carbamazepine | SUSPENSION;ORAL | 214277 | ANDA | ANI Pharmaceuticals, Inc. | 70954-240 | 70954-240-10 | 1 BOTTLE in 1 CARTON (70954-240-10) / 450 mL in 1 BOTTLE |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | SUSPENSION;ORAL | Strength | 100MG/5ML | ||||
| Approval Date: | Oct 6, 2022 | TE: | AB | RLD: | No | ||||
Complete Access Available with Subscription
