Details for New Drug Application (NDA): 077272

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NDA 077272 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.

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	077272	ANDA	Major Pharmaceuticals	0904-6172	0904-6172-50	2000 TABLET in 1 BOTTLE (0904-6172-50)
CARBAMAZEPINE	carbamazepine	TABLET;ORAL	077272	ANDA	Major Pharmaceuticals	0904-6172	0904-6172-61	100 BLISTER PACK in 1 CARTON (0904-6172-61) / 1 TABLET in 1 BLISTER PACK

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	100MG
Approval Date:	Dec 7, 2005	TE:	AB	RLD:	No

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	200MG
Approval Date:	Dec 7, 2005	TE:	AB	RLD:	No

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	300MG
Approval Date:	Dec 7, 2005	TE:		RLD:	No

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