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Last Updated: July 8, 2020

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Details for New Drug Application (NDA): 070541

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NDA 070541 describes EPITOL, which is a drug marketed by Teva and is included in two NDAs. It is available from three suppliers. Additional details are available on the EPITOL profile page.

The generic ingredient in EPITOL is carbamazepine. There are twenty-seven drug master file entries for this compound. Thirty-five suppliers are listed for this compound. Additional details are available on the carbamazepine profile page.
Summary for 070541
Formulation / Manufacturing:see details
Suppliers and Packaging for NDA: 070541
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
EPITOL carbamazepine TABLET;ORAL 070541 ANDA Teva Pharmaceuticals USA, Inc. 0093-0090 0093-0090-01 100 TABLET in 1 BOTTLE (0093-0090-01)
EPITOL carbamazepine TABLET;ORAL 070541 ANDA Teva Pharmaceuticals USA, Inc. 0093-0109 0093-0109-01 100 TABLET in 1 BOTTLE (0093-0109-01)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength200MG
Approval Date:Sep 17, 1986TE:ABRLD:No

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