Details for New Drug Application (NDA): 212256
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NDA 212256 describes TAVABOROLE, which is a drug marketed by Alembic, Amneal, Chartwell Rx, Cipla, Encube, Lupin Ltd, Padagis Us, Taro, and Zydus Lifesciences, and is included in nine NDAs. It is available from ten suppliers. Additional details are available on the TAVABOROLE profile page.
The generic ingredient in TAVABOROLE is tavaborole. There are six drug master file entries for this compound. Ten suppliers are listed for this compound. Additional details are available on the tavaborole profile page.
The generic ingredient in TAVABOROLE is tavaborole. There are six drug master file entries for this compound. Ten suppliers are listed for this compound. Additional details are available on the tavaborole profile page.
Summary for 212256
| Tradename: | TAVABOROLE |
| Applicant: | Amneal |
| Ingredient: | tavaborole |
| Patents: | 0 |
Pharmacology for NDA: 212256
| Mechanism of Action | Protein Synthesis Inhibitors |
Suppliers and Packaging for NDA: 212256
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| TAVABOROLE | tavaborole | SOLUTION;TOPICAL | 212256 | ANDA | Amneal Pharmaceuticals NY LLC | 69238-1657 | 69238-1657-4 | 1 BOTTLE, WITH APPLICATOR in 1 CARTON (69238-1657-4) / 4 mL in 1 BOTTLE, WITH APPLICATOR |
| TAVABOROLE | tavaborole | SOLUTION;TOPICAL | 212256 | ANDA | Amneal Pharmaceuticals NY LLC | 69238-1657 | 69238-1657-6 | 1 BOTTLE, WITH APPLICATOR in 1 CARTON (69238-1657-6) / 10 mL in 1 BOTTLE, WITH APPLICATOR |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | SOLUTION;TOPICAL | Strength | 5% | ||||
| Approval Date: | Nov 25, 2020 | TE: | AB | RLD: | No | ||||
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