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Last Updated: March 16, 2025

Details for New Drug Application (NDA): 216404

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NDA 216404 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 216404

Tradename:	CARBAMAZEPINE
Applicant:	Novast Labs
Ingredient:	carbamazepine
Patents:	0

Pharmacology for NDA: 216404

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 216404

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

Suppliers and Packaging for NDA: 216404

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
CARBAMAZEPINE	carbamazepine	TABLET, EXTENDED RELEASE;ORAL	216404	ANDA	Ingenus Pharmaceuticals, LLC	50742-257	50742-257-01	100 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (50742-257-01)
CARBAMAZEPINE	carbamazepine	TABLET, EXTENDED RELEASE;ORAL	216404	ANDA	Ingenus Pharmaceuticals, LLC	50742-258	50742-258-01	100 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (50742-258-01)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET, EXTENDED RELEASE;ORAL			Strength	100MG
Approval Date:	Dec 2, 2022	TE:	AB	RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET, EXTENDED RELEASE;ORAL			Strength	200MG
Approval Date:	Dec 2, 2022	TE:	AB	RLD:	No

Profile for product number 003

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET, EXTENDED RELEASE;ORAL			Strength	400MG
Approval Date:	Dec 2, 2022	TE:	AB	RLD:	No

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