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Details for New Drug Application (NDA): 016608

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NDA 016608 describes TEGRETOL, which is a drug marketed by Novartis and is included in four NDAs. It is available from two suppliers. Additional details are available on the TEGRETOL profile page.

The generic ingredient in TEGRETOL is carbamazepine. There are twenty-seven drug master file entries for this compound. Forty-one suppliers are listed for this compound. There are three tentative approvals for this compound. Additional details are available on the carbamazepine profile page.

Suppliers and Packaging for NDA: 016608

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
TABLET;ORAL 016608 NDA Novartis Pharmaceuticals Corporation 0078-0509 0078-0509-05 100 TABLET in 1 BOTTLE (0078-0509-05)
TABLET;ORAL 016608 NDA REMEDYREPACK INC. 61786-445 61786-445-02 30 TABLET in 1 BLISTER PACK (61786-445-02)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength200MG
Approval Date:Approved Prior to Jan 1, 1982TE:ABRLD:Yes

Expired Orange Book Patents for NDA: 016608

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Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
TABLET;ORAL016608-001Approved Prior to Jan 1, 19824,409,212<disabled>
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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 verifification 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.