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Last Updated: December 28, 2025

Details for New Drug Application (NDA): 075948

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NDA 075948 describes CARBAMAZEPINE, which is a drug marketed by Ani Pharms, Apotex Inc, Taro, Teva Pharms, Chartwell Rx, Novitium Pharma, Jubilant Cadista, Taro Pharm Inds, Torrent Pharms, Ajanta Pharma Ltd, Alembic, Alkem Labs Ltd, Amneal Pharms, Anbison Lab, Apotex, Cspc Ouyi, Novast Labs, Osmotica Pharm Us, Sciecure Pharma Inc, 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 forty NDAs. It is available from forty-four 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-nine suppliers are listed for this compound. Additional details are available on the carbamazepine profile page.

Summary for 075948

Tradename:	CARBAMAZEPINE
Applicant:	Apotex
Ingredient:	carbamazepine
Patents:	0

Pharmacology for NDA: 075948

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

Medical Subject Heading (MeSH) Categories for 075948

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

Suppliers and Packaging for NDA: 075948

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
CARBAMAZEPINE	carbamazepine	TABLET;ORAL	075948	ANDA	Aphena Pharma Solutions - Tennessee, LLC	43353-953	43353-953-53	60 TABLET in 1 BOTTLE (43353-953-53)
CARBAMAZEPINE	carbamazepine	TABLET;ORAL	075948	ANDA	Aphena Pharma Solutions - Tennessee, LLC	43353-953	43353-953-60	90 TABLET in 1 BOTTLE (43353-953-60)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	200MG
Approval Date:	Feb 27, 2002	TE:	AB	RLD:	No

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