➤ Get the DrugPatentWatch Daily Briefing

Get Daily Updates on Generic Entry, Litigation, Biosimilars, and more …

Serving leading biopharmaceutical companies globally:

AstraZeneca
Johnson and Johnson
Express Scripts
Merck
Colorcon
Medtronic

Last Updated: July 29, 2021

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 205571


Email this page to a colleague

« Back to Dashboard

NDA 205571 describes CARBAMAZEPINE, which is a drug marketed by Apotex Inc, Nostrum Labs Inc, Taro, Teva Pharms, Wockhardt Bio Ag, Jubilant Cadista, Taro Pharm Inds, Torrent Pharms, Cspc Ouyi, Unique Pharm, Zydus Pharms, Actavis Elizabeth, Inwood Labs, Pliva, Umedica Labs Pvt Ltd, Usl Pharma, and Warner Chilcott, and is included in twenty-two NDAs. It is available from twenty-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. Thirty-six suppliers are listed for this compound. Additional details are available on the carbamazepine profile page.
Summary for 205571
Tradename:CARBAMAZEPINE
Applicant:Zydus Pharms
Ingredient:carbamazepine
Patents:0
Formulation / Manufacturing:see details
Suppliers and Packaging for NDA: 205571
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
CARBAMAZEPINE carbamazepine TABLET, EXTENDED RELEASE;ORAL 205571 ANDA Northstar Rx LLC 16714-063 16714-063-01 100 TABLET, EXTENDED RELEASE in 1 BOTTLE (16714-063-01)
CARBAMAZEPINE carbamazepine TABLET, EXTENDED RELEASE;ORAL 205571 ANDA Northstar Rx LLC 16714-064 16714-064-01 100 TABLET, EXTENDED RELEASE in 1 BOTTLE (16714-064-01)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET, EXTENDED RELEASE;ORALStrength100MG
Approval Date:Feb 7, 2019TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET, EXTENDED RELEASE;ORALStrength200MG
Approval Date:Feb 7, 2019TE:ABRLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET, EXTENDED RELEASE;ORALStrength400MG
Approval Date:Feb 7, 2019TE:ABRLD:No

Complete Access Available with Subscription

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

Serving leading biopharmaceutical companies globally:

McKesson
Merck
Express Scripts
Harvard Business School
Colorcon
Boehringer Ingelheim

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. 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.