Details for New Drug Application (NDA): 021385
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The generic ingredient in ERTACZO is sertaconazole nitrate. There is one drug master file entry for this compound. One supplier is listed for this compound. Additional details are available on the sertaconazole nitrate profile page.
Summary for 021385
Tradename: | ERTACZO |
Applicant: | Lacer Pharma |
Ingredient: | sertaconazole nitrate |
Patents: | 0 |
Suppliers and Packaging for NDA: 021385
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
ERTACZO | sertaconazole nitrate | CREAM;TOPICAL | 021385 | NDA | Bausch Health US, LLC | 0187-5115 | 0187-5115-60 | 1 TUBE in 1 CARTON (0187-5115-60) / 60 g in 1 TUBE |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | CREAM;TOPICAL | Strength | 2% | ||||
Approval Date: | Dec 10, 2003 | TE: | RLD: | Yes |
Expired US Patents for NDA 021385
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Lacer Pharma | ERTACZO | sertaconazole nitrate | CREAM;TOPICAL | 021385-001 | Dec 10, 2003 | ⤷ Try a Trial | ⤷ Try a Trial |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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