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Last Updated: December 19, 2025

Details for New Drug Application (NDA): 078986

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NDA 078986 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 078986

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

Pharmacology for NDA: 078986

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 078986

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

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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