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Last Updated: March 16, 2025

Details for New Drug Application (NDA): 219072

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NDA 219072 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, Alkem Labs Ltd, Amneal Pharms, Anbison Lab, Apotex, Cspc Ouyi, Epic Pharma Llc, Novast Labs, Osmotica Pharm Us, Torrent, Umedica, Unique Pharm, Yichang Humanwell, Zhejiang Jiuzhou, Zydus Pharms, Actavis Elizabeth, Bionpharma, Inwood Labs, Pliva, Rk Pharma, Unichem, Usl Pharma, and Warner Chilcott, and is included in thirty-eight NDAs. It is available from thirty-nine 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-four suppliers are listed for this compound. Additional details are available on the carbamazepine profile page.

Summary for 219072

Tradename:	CARBAMAZEPINE
Applicant:	Yichang Humanwell
Ingredient:	carbamazepine
Patents:	0

Medical Subject Heading (MeSH) Categories for 219072

Analgesics, Non-Narcotic
Anticonvulsants
Antimanic Agents
Cytochrome P-450 CYP3A Inducers

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET, EXTENDED RELEASE;ORAL			Strength	100MG
Approval Date:	Jan 16, 2025	TE:	AB	RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET, EXTENDED RELEASE;ORAL			Strength	200MG
Approval Date:	Jan 16, 2025	TE:	AB	RLD:	No

Profile for product number 003

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET, EXTENDED RELEASE;ORAL			Strength	400MG
Approval Date:	Jan 16, 2025	TE:	AB	RLD:	No

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