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Generated: January 21, 2019

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Details for New Drug Application (NDA): 073524

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NDA 073524 describes EPITOL, which is a drug marketed by Teva and is included in two NDAs. It is available from four 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-nine suppliers are listed for this compound. Additional details are available on the carbamazepine profile page.
Summary for 073524
Formulation / Manufacturing:see details
Suppliers and Packaging for NDA: 073524
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
EPITOL carbamazepine TABLET, CHEWABLE;ORAL 073524 ANDA Teva Pharmaceuticals USA, Inc. 0093-0778 0093-0778-01 100 TABLET, CHEWABLE in 1 BOTTLE (0093-0778-01)
EPITOL carbamazepine TABLET, CHEWABLE;ORAL 073524 ANDA Mylan Institutional Inc. 51079-870 51079-870-20 100 BLISTER PACK in 1 CARTON (51079-870-20) > 1 TABLET, CHEWABLE in 1 BLISTER PACK (51079-870-01)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET, CHEWABLE;ORALStrength100MG
Approval Date:Jul 29, 1992TE:ABRLD:No

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