DrugPatentWatch Database Preview
Details for New Drug Application (NDA): 075953
NDA 075953 describes TERCONAZOLE, which is a drug marketed by Fougera Pharms, Nycomed Us, Taro, and Perrigo New York, and is included in seven NDAs. It is available from eleven 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. Fourteen 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. Fourteen suppliers are listed for this compound. Additional details are available on the terconazole profile page.
Summary for 075953
| Tradename: | TERCONAZOLE |
| Applicant: | Taro |
| Ingredient: | terconazole |
| Patents: | 0 |
| Formulation / Manufacturing: | see details |
Pharmacology for NDA: 075953
| Ingredient-type | Azoles |
Suppliers and Packaging for NDA: 075953
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| TERCONAZOLE | terconazole | CREAM;VAGINAL | 075953 | ANDA | A-S Medication Solutions | 50090-1196 | 50090-1196-0 | 1 TUBE, WITH APPLICATOR in 1 CARTON (50090-1196-0) > 20 g in 1 TUBE, WITH APPLICATOR |
| TERCONAZOLE | terconazole | CREAM;VAGINAL | 075953 | ANDA | Taro Pharmaceuticals U.S.A., Inc. | 51672-1302 | 51672-1302-0 | 1 TUBE, WITH APPLICATOR in 1 CARTON (51672-1302-0) > 20 g in 1 TUBE, WITH APPLICATOR |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | CREAM;VAGINAL | Strength | 0.8% | ||||
| Approval Date: | Apr 6, 2004 | TE: | BX | RLD: | No | ||||
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