Details for New Drug Application (NDA): 212215
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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 212215
Tradename: | TAVABOROLE |
Applicant: | Taro |
Ingredient: | tavaborole |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Pharmacology for NDA: 212215
Mechanism of Action | Protein Synthesis Inhibitors |
Suppliers and Packaging for NDA: 212215
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
TAVABOROLE | tavaborole | SOLUTION;TOPICAL | 212215 | ANDA | Taro Pharmaceuticals U.S.A., Inc. | 51672-1397 | 51672-1397-9 | 1 BOTTLE, WITH APPLICATOR in 1 CARTON (51672-1397-9) / 10 mL in 1 BOTTLE, WITH APPLICATOR |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | SOLUTION;TOPICAL | Strength | 5% | ||||
Approval Date: | May 7, 2021 | TE: | AB | RLD: | No |
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