Last Updated: June 9, 2026

Details for New Drug Application (NDA): 075714

✉ Email this page to a colleague

« Back to Dashboard

NDA 075714 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, Ingenus Pharms Llc, 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-two 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-seven suppliers are listed for this compound. Additional details are available on the carbamazepine profile page.

Summary for 075714

Tradename:	CARBAMAZEPINE
Applicant:	Chartwell Rx
Ingredient:	carbamazepine
Patents:	0

Pharmacology for NDA: 075714

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 075714

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

Suppliers and Packaging for NDA: 075714

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
CARBAMAZEPINE	carbamazepine	SUSPENSION;ORAL	075714	ANDA	Chartwell RX, LLC	62135-802	62135-802-24	2 TRAY in 1 BOX (62135-802-24) / 10 PACKAGE in 1 TRAY / 5 mL in 1 PACKAGE (62135-802-45)
CARBAMAZEPINE	carbamazepine	SUSPENSION;ORAL	075714	ANDA	Chartwell RX, LLC	62135-802	62135-802-53	450 mL in 1 BOTTLE (62135-802-53)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	SUSPENSION;ORAL			Strength	100MG/5ML
Approval Date:	Jun 5, 2002	TE:	AB	RLD:	No

Complete Access Available with Subscription

Make Better Decisions: Try a trial or see plans & pricing

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. We do not provide individual investment advice. This service is not registered with any financial regulatory agency. The information we publish is educational only and based on our opinions plus our models. By using DrugPatentWatch you acknowledge that we do not provide personalized recommendations or advice. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.