Details for New Drug Application (NDA): 217628
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NDA 217628 describes CLOTIC, which is a drug marketed by Carwin Pharm Assoc and is included in one NDA. It is available from one supplier. There is one patent protecting this drug. Additional details are available on the CLOTIC profile page.
The generic ingredient in CLOTIC is clotrimazole. There are eleven drug master file entries for this compound. Thirty suppliers are listed for this compound. Additional details are available on the clotrimazole profile page.
The generic ingredient in CLOTIC is clotrimazole. There are eleven drug master file entries for this compound. Thirty suppliers are listed for this compound. Additional details are available on the clotrimazole profile page.
Summary for 217628
| Tradename: | CLOTIC |
| Applicant: | Carwin Pharm Assoc |
| Ingredient: | clotrimazole |
| Patents: | 1 |
Suppliers and Packaging for NDA: 217628
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| CLOTIC | clotrimazole | SOLUTION/DROPS;OTIC | 217628 | NDA | Carwin Pharmaceutical Associates, LLC | 15370-220 | 15370-220-28 | 2 POUCH in 1 CARTON (15370-220-28) / 14 VIAL, SINGLE-DOSE in 1 POUCH / .17 mL in 1 VIAL, SINGLE-DOSE |
| CLOTIC | clotrimazole | SOLUTION/DROPS;OTIC | 217628 | NDA | Carwin Pharmaceutical Associates, LLC | 15370-220 | 15370-220-99 | 1 POUCH in 1 CARTON (15370-220-99) / 2 VIAL, SINGLE-DOSE in 1 POUCH / .17 mL in 1 VIAL, SINGLE-DOSE |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | SOLUTION/DROPS;OTIC | Strength | 1% | ||||
| Approval Date: | Sep 26, 2025 | TE: | RLD: | Yes | |||||
| Regulatory Exclusivity Expiration: | Sep 26, 2033 | ||||||||
| Regulatory Exclusivity Use: | GENERATING ANTIBIOTIC INCENTIVES NOW | ||||||||
| Regulatory Exclusivity Expiration: | Sep 26, 2028 | ||||||||
| Regulatory Exclusivity Use: | NEW PRODUCT | ||||||||
| Patent: | 12,246,006 | Patent Expiration: | May 26, 2042 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
| Patented Use: | TREATMENT OF FUNGAL OTIC INFECTION (FUNGAL OTITIS EXTERNA, OTOMYCOSIS) DUE TO ASPERGILLUS SPECIES AND CANDIDA SPECIES | ||||||||
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