Details for New Drug Application (NDA): 200923
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NDA 200923 describes GYNAZOLE-1, which is a drug marketed by Padagis Israel and is included in one NDA. It is available from one supplier. Additional details are available on the GYNAZOLE-1 profile page.
The generic ingredient in GYNAZOLE-1 is butoconazole nitrate. There are six drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the butoconazole nitrate profile page.
The generic ingredient in GYNAZOLE-1 is butoconazole nitrate. There are six drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the butoconazole nitrate profile page.
Summary for 200923
| Tradename: | GYNAZOLE-1 |
| Applicant: | Padagis Israel |
| Ingredient: | butoconazole nitrate |
| Patents: | 0 |
Suppliers and Packaging for NDA: 200923
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| GYNAZOLE-1 | butoconazole nitrate | CREAM;VAGINAL | 200923 | ANDA | Padagis Israel Pharmaceuticals Ltd | 45802-396 | 45802-396-01 | 1 TUBE, WITH APPLICATOR in 1 CARTON (45802-396-01) / 5.8 g in 1 TUBE, WITH APPLICATOR |
| GYNAZOLE-1 | butoconazole nitrate | CREAM;VAGINAL | 200923 | ANDA | Padagis Israel Pharmaceuticals Ltd | 45802-396 | 45802-396-02 | 1 TUBE, WITH APPLICATOR in 1 CARTON (45802-396-02) / 5.8 g in 1 TUBE, WITH APPLICATOR |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | CREAM;VAGINAL | Strength | 2% | ||||
| Approval Date: | May 18, 2012 | TE: | RLD: | No | |||||
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