Details for New Drug Application (NDA): 213284

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NDA 213284 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, Osmotica Pharm Us, 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-five 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-five suppliers are listed for this compound. Additional details are available on the carbamazepine profile page.

Mechanism of Action	Cytochrome P450 1A2 Inducers Cytochrome P450 2B6 Inducers Cytochrome P450 2C19 Inducers Cytochrome P450 2C9 Inducers Cytochrome P450 3A4 Inducers
Physiological Effect	Decreased Central Nervous System Disorganized Electrical Activity

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
CARBAMAZEPINE	carbamazepine	TABLET;ORAL	213284	ANDA	Unichem Pharmaceuticals (USA), Inc.	29300-382	29300-382-01	100 TABLET in 1 BOTTLE (29300-382-01)
CARBAMAZEPINE	carbamazepine	TABLET;ORAL	213284	ANDA	Unichem Pharmaceuticals (USA), Inc.	29300-382	29300-382-05	500 TABLET in 1 BOTTLE (29300-382-05)

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	200MG
Approval Date:	Aug 22, 2022	TE:	AB	RLD:	No

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