Details for New Drug Application (NDA): 218273
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NDA 218273 describes CIPROFLOXACIN HYDROCHLORIDE AND HYDROCORTISONE, which is a drug marketed by Cosette Pharms Nc and is included in one NDA. It is available from one supplier. Additional details are available on the CIPROFLOXACIN HYDROCHLORIDE AND HYDROCORTISONE profile page.
The generic ingredient in CIPROFLOXACIN HYDROCHLORIDE AND HYDROCORTISONE is ciprofloxacin hydrochloride; hydrocortisone. There are thirty-four drug master file entries for this compound. Four suppliers are listed for this compound. Additional details are available on the ciprofloxacin hydrochloride; hydrocortisone profile page.
The generic ingredient in CIPROFLOXACIN HYDROCHLORIDE AND HYDROCORTISONE is ciprofloxacin hydrochloride; hydrocortisone. There are thirty-four drug master file entries for this compound. Four suppliers are listed for this compound. Additional details are available on the ciprofloxacin hydrochloride; hydrocortisone profile page.
Summary for 218273
| Tradename: | CIPROFLOXACIN HYDROCHLORIDE AND HYDROCORTISONE |
| Applicant: | Cosette Pharms Nc |
| Ingredient: | ciprofloxacin hydrochloride; hydrocortisone |
| Patents: | 0 |
Pharmacology for NDA: 218273
| Mechanism of Action | Corticosteroid Hormone Receptor Agonists Cytochrome P450 1A2 Inhibitors |
Suppliers and Packaging for NDA: 218273
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| CIPROFLOXACIN HYDROCHLORIDE AND HYDROCORTISONE | ciprofloxacin hydrochloride; hydrocortisone | SUSPENSION/DROPS;OTIC | 218273 | ANDA | Cosette Pharmaceuticals, Inc. | 0713-0851 | 0713-0851-09 | 1 BOTTLE in 1 CARTON (0713-0851-09) / 10 mL in 1 BOTTLE |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | SUSPENSION/DROPS;OTIC | Strength | EQ 0.2% BASE;1% | ||||
| Approval Date: | Nov 10, 2025 | TE: | AB | RLD: | No | ||||
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