Details for New Drug Application (NDA): 212188
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NDA 212188 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 eleven 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. Eleven 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. Eleven suppliers are listed for this compound. Additional details are available on the tavaborole profile page.
Summary for 212188
| Tradename: | TAVABOROLE |
| Applicant: | Alembic |
| Ingredient: | tavaborole |
| Patents: | 0 |
| Formulation / Manufacturing: | see details |
Pharmacology for NDA: 212188
| Mechanism of Action | Protein Synthesis Inhibitors |
Suppliers and Packaging for NDA: 212188
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| TAVABOROLE | tavaborole | SOLUTION;TOPICAL | 212188 | ANDA | Alembic Pharmaceuticals Inc. | 62332-467 | 62332-467-04 | 1 BOTTLE, DROPPER in 1 CARTON (62332-467-04) / 4 mL in 1 BOTTLE, DROPPER |
| TAVABOROLE | tavaborole | SOLUTION;TOPICAL | 212188 | ANDA | Alembic Pharmaceuticals Inc. | 62332-467 | 62332-467-10 | 1 BOTTLE, DROPPER in 1 CARTON (62332-467-10) / 10 mL in 1 BOTTLE, DROPPER |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | SOLUTION;TOPICAL | Strength | 5% | ||||
| Approval Date: | Oct 21, 2020 | TE: | AB | RLD: | No | ||||
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