DrugPatentWatch Database Preview
Details for New Drug Application (NDA): 076327
NDA 076327 describes TOPIRAMATE, which is a drug marketed by Zydus Pharms Usa Inc, Barr, Fosun Pharma, Mylan, Teva, Watson Labs, Accord Hlthcare, Actavis Totowa, Apotex Inc, Aurobindo Pharma, Cipla Ltd, Glenmark Generics, Invagen Pharms, Lupin, Pliva Hrvatska Doo, Roxane, Sun Pharm Inds Ltd, Sun Pharma Global, Torrent Pharms, Unichem Labs Ltd, Upsher-smith Labs, Wockhardt Usa, and Hikma Pharms, and is included in twenty-nine NDAs. It is available from forty-eight suppliers. Additional details are available on the TOPIRAMATE profile page.
The generic ingredient in TOPIRAMATE is topiramate. There are twenty-six drug master file entries for this compound. Fifty-two suppliers are listed for this compound. Additional details are available on the topiramate profile page.
The generic ingredient in TOPIRAMATE is topiramate. There are twenty-six drug master file entries for this compound. Fifty-two suppliers are listed for this compound. Additional details are available on the topiramate profile page.
Summary for 076327
| Tradename: | TOPIRAMATE |
| Applicant: | Sun Pharm Inds Ltd |
| Ingredient: | topiramate |
| Patents: | 0 |
| Therapeutic Class: | Anticonvulsants Antimigraine Agents |
| Formulation / Manufacturing: | see details |
Pharmacology for NDA: 076327
| Mechanism of Action | Cytochrome P450 3A4 Inducers Cytochrome P450 2C19 Inhibitors |
| Physiological Effect | Decreased Central Nervous System Disorganized Electrical Activity |
Suppliers and Packaging for NDA: 076327
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| TOPIRAMATE | topiramate | TABLET;ORAL | 076327 | ANDA | Ranbaxy Pharmaceuticals Inc | 63304-778 | N | 63304-778-10 |
| TOPIRAMATE | topiramate | TABLET;ORAL | 076327 | ANDA | Ranbaxy Pharmaceuticals Inc | 63304-778 | N | 63304-778-30 |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 25MG | ||||
| Approval Date: | Mar 27, 2009 | TE: | AB | RLD: | No | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 100MG | ||||
| Approval Date: | Mar 27, 2009 | TE: | AB | RLD: | No | ||||
Profile for product number 003
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 200MG | ||||
| Approval Date: | Mar 27, 2009 | TE: | AB | RLD: | No | ||||
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