Details for New Drug Application (NDA): 078986
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NDA 078986 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 078986
| Tradename: | CARBAMAZEPINE |
| Applicant: | Apotex Inc |
| Ingredient: | carbamazepine |
| Patents: | 0 |
Suppliers and Packaging for NDA: 078986
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| CARBAMAZEPINE | carbamazepine | CAPSULE, EXTENDED RELEASE;ORAL | 078986 | ANDA | Major Pharmaceuticals | 0904-6885 | 0904-6885-04 | 30 BLISTER PACK in 1 CARTON (0904-6885-04) / 1 CAPSULE, EXTENDED RELEASE in 1 BLISTER PACK |
| CARBAMAZEPINE | carbamazepine | CAPSULE, EXTENDED RELEASE;ORAL | 078986 | ANDA | AvPAK | 50268-170 | 50268-170-13 | 30 BLISTER PACK in 1 BOX (50268-170-13) / 1 CAPSULE, EXTENDED RELEASE in 1 BLISTER PACK (50268-170-11) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE, EXTENDED RELEASE;ORAL | Strength | 100MG | ||||
| Approval Date: | Nov 25, 2011 | TE: | AB | RLD: | No | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE, EXTENDED RELEASE;ORAL | Strength | 200MG | ||||
| Approval Date: | Nov 25, 2011 | TE: | AB | RLD: | No | ||||
Profile for product number 003
| Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE, EXTENDED RELEASE;ORAL | Strength | 300MG | ||||
| Approval Date: | Nov 25, 2011 | TE: | AB | RLD: | No | ||||
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