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 two 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. Forty-nine suppliers are listed for this compound. Additional details are available on the carbamazepine profile page.
The generic ingredient in EPITOL is carbamazepine. There are twenty-seven drug master file entries for this compound. Forty-nine suppliers are listed for this compound. Additional details are available on the carbamazepine profile page.
Summary for 073524
| Tradename: | EPITOL |
| Applicant: | Teva |
| Ingredient: | carbamazepine |
| Patents: | 0 |
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 | Bryant Ranch Prepack | 63629-9292 | 63629-9292-1 | 100 TABLET, CHEWABLE in 1 BOTTLE (63629-9292-1) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET, CHEWABLE;ORAL | Strength | 100MG | ||||
| Approval Date: | Jul 29, 1992 | TE: | AB | RLD: | No | ||||
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