Details for New Drug Application (NDA): 077149
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NDA 077149 describes TERCONAZOLE, which is a drug marketed by Fougera Pharms, Fougera Pharms Inc, Taro, and Padagis Israel, and is included in seven NDAs. It is available from seven suppliers. Additional details are available on the TERCONAZOLE profile page.
The generic ingredient in TERCONAZOLE is terconazole. There are six drug master file entries for this compound. Seven suppliers are listed for this compound. Additional details are available on the terconazole profile page.
The generic ingredient in TERCONAZOLE is terconazole. There are six drug master file entries for this compound. Seven suppliers are listed for this compound. Additional details are available on the terconazole profile page.
Summary for 077149
| Tradename: | TERCONAZOLE |
| Applicant: | Padagis Israel |
| Ingredient: | terconazole |
| Patents: | 0 |
| Formulation / Manufacturing: | see details |
Suppliers and Packaging for NDA: 077149
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| TERCONAZOLE | terconazole | SUPPOSITORY;VAGINAL | 077149 | ANDA | Padagis Israel Pharmaceuticals Ltd | 45802-717 | 45802-717-08 | 3 BLISTER PACK in 1 CARTON (45802-717-08) / 1 SUPPOSITORY in 1 BLISTER PACK (45802-717-00) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | SUPPOSITORY;VAGINAL | Strength | 80MG | ||||
| Approval Date: | Mar 17, 2006 | TE: | AB | RLD: | No | ||||
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