Details for New Drug Application (NDA): 075953
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NDA 075953 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 eight 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. Eight 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. Eight 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 |
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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