Details for New Drug Application (NDA): 217075
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NDA 217075 describes TAZAROTENE, which is a drug marketed by Cosette, Fougera Pharms Inc, Padagis Israel, Taro, and Solaris Pharma Corp, and is included in eight NDAs. It is available from six suppliers. Additional details are available on the TAZAROTENE profile page.
The generic ingredient in TAZAROTENE is tazarotene. There are eight drug master file entries for this compound. Eleven suppliers are listed for this compound. Additional details are available on the tazarotene profile page.
The generic ingredient in TAZAROTENE is tazarotene. There are eight drug master file entries for this compound. Eleven suppliers are listed for this compound. Additional details are available on the tazarotene profile page.
Summary for 217075
| Tradename: | TAZAROTENE |
| Applicant: | Padagis Israel |
| Ingredient: | tazarotene |
| Patents: | 0 |
Suppliers and Packaging for NDA: 217075
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| TAZAROTENE | tazarotene | CREAM;TOPICAL | 217075 | ANDA | Padagis Israel Pharmaceuticals Ltd | 45802-706 | 45802-706-94 | 1 TUBE in 1 CARTON (45802-706-94) / 30 g in 1 TUBE |
| TAZAROTENE | tazarotene | CREAM;TOPICAL | 217075 | ANDA | Padagis Israel Pharmaceuticals Ltd | 45802-706 | 45802-706-96 | 1 TUBE in 1 CARTON (45802-706-96) / 60 g in 1 TUBE |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | CREAM;TOPICAL | Strength | 0.05% | ||||
| Approval Date: | Jul 15, 2024 | TE: | AB | RLD: | No | ||||
| Regulatory Exclusivity Expiration: | Mar 8, 2025 | ||||||||
| Regulatory Exclusivity Use: | COMPETITIVE GENERIC THERAPY | ||||||||
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