Details for New Drug Application (NDA): 076479
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NDA 076479 describes ECONAZOLE NITRATE, which is a drug marketed by Aurobindo Pharma Usa, Chartwell Rx, Encube, Padagis Israel, and Taro, and is included in five NDAs. It is available from five suppliers. Additional details are available on the ECONAZOLE NITRATE profile page.
The generic ingredient in ECONAZOLE NITRATE is econazole nitrate. There are eleven drug master file entries for this compound. Six suppliers are listed for this compound. Additional details are available on the econazole nitrate profile page.
The generic ingredient in ECONAZOLE NITRATE is econazole nitrate. There are eleven drug master file entries for this compound. Six suppliers are listed for this compound. Additional details are available on the econazole nitrate profile page.
Summary for 076479
| Tradename: | ECONAZOLE NITRATE |
| Applicant: | Padagis Israel |
| Ingredient: | econazole nitrate |
| Patents: | 0 |
Suppliers and Packaging for NDA: 076479
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| ECONAZOLE NITRATE | econazole nitrate | CREAM;TOPICAL | 076479 | ANDA | Padagis Israel Pharmaceuticals Ltd | 45802-466 | 45802-466-11 | 1 TUBE in 1 CARTON (45802-466-11) / 30 g in 1 TUBE |
| ECONAZOLE NITRATE | econazole nitrate | CREAM;TOPICAL | 076479 | ANDA | Padagis Israel Pharmaceuticals Ltd | 45802-466 | 45802-466-35 | 1 TUBE in 1 CARTON (45802-466-35) / 15 g in 1 TUBE |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | CREAM;TOPICAL | Strength | 1% | ||||
| Approval Date: | Jun 23, 2004 | TE: | AB | RLD: | No | ||||
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