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Generated: January 23, 2019

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Details for New Drug Application (NDA): 076729

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NDA 076729 describes TERIL, which is a drug marketed by Taro Pharm and Taro and is included in two NDAs. It is available from two suppliers. Additional details are available on the TERIL profile page.

The generic ingredient in TERIL is carbamazepine. There are twenty-seven drug master file entries for this compound. Thirty-eight suppliers are listed for this compound. Additional details are available on the carbamazepine profile page.
Summary for 076729
Applicant:Taro Pharm
Formulation / Manufacturing:see details
Suppliers and Packaging for NDA: 076729
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
TERIL carbamazepine SUSPENSION;ORAL 076729 ANDA Atlantic Biologicals Corps 17856-4047 17856-4047-1 10 mL in 1 CUP (17856-4047-1)
TERIL carbamazepine SUSPENSION;ORAL 076729 ANDA Taro Pharmaceuticals U.S.A., Inc. 51672-4047 51672-4047-9 450 mL in 1 BOTTLE (51672-4047-9)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:SUSPENSION;ORALStrength100MG/5ML
Approval Date:Sep 20, 2004TE:ABRLD:No

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Serving hundreds of leading biopharmaceutical companies globally:

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