Details for New Drug Application (NDA): 217887
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NDA 217887 describes CIPROFLOXACIN HYDROCHLORIDE, which is a drug marketed by Altaire Pharms Inc, Amring Pharms, Fdc Ltd, Pharmobedient, Rising, Rubicon Research, The J Molner, Watson Labs Inc, New Heightsrx, Aiping Pharm Inc, Amneal, Aurobindo Pharma, Barr, Carlsbad, Chartwell, Dr Reddys Labs Ltd, Hikma, Ivax Sub Teva Pharms, Natco, Nostrum Labs, Pliva, Sun Pharm Inds Ltd, Taro, Teva, Unique, Watson Labs, Yiling, and Cosette Pharms Nc, and is included in twenty-nine NDAs. It is available from fifty-four suppliers. Additional details are available on the CIPROFLOXACIN HYDROCHLORIDE profile page.
The generic ingredient in CIPROFLOXACIN HYDROCHLORIDE is ciprofloxacin hydrochloride; hydrocortisone. There are thirty-four drug master file entries for this compound. Five suppliers are listed for this compound. Additional details are available on the ciprofloxacin hydrochloride; hydrocortisone profile page.
The generic ingredient in CIPROFLOXACIN HYDROCHLORIDE is ciprofloxacin hydrochloride; hydrocortisone. There are thirty-four drug master file entries for this compound. Five suppliers are listed for this compound. Additional details are available on the ciprofloxacin hydrochloride; hydrocortisone profile page.
Summary for 217887
| Tradename: | CIPROFLOXACIN HYDROCHLORIDE |
| Applicant: | New Heightsrx |
| Ingredient: | ciprofloxacin hydrochloride |
| Patents: | 0 |
Pharmacology for NDA: 217887
| Mechanism of Action | Cytochrome P450 1A2 Inhibitors |
Suppliers and Packaging for NDA: 217887
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| CIPROFLOXACIN HYDROCHLORIDE | ciprofloxacin hydrochloride | SOLUTION/DROPS;OTIC | 217887 | ANDA | Genus Lifesciences | 64950-381 | 64950-381-14 | 14 VIAL in 1 CARTON (64950-381-14) / .25 mL in 1 VIAL |
| CIPROFLOXACIN HYDROCHLORIDE | ciprofloxacin hydrochloride | SOLUTION/DROPS;OTIC | 217887 | ANDA | Virtus Pharmaceuticals, LLC | 69543-457 | 69543-457-14 | 14 VIAL, SINGLE-DOSE in 1 CARTON (69543-457-14) / .25 mL in 1 VIAL, SINGLE-DOSE |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | SOLUTION/DROPS;OTIC | Strength | EQ 0.2% BASE | ||||
| Approval Date: | Nov 5, 2024 | TE: | AB | RLD: | No | ||||
| Regulatory Exclusivity Expiration: | Jun 11, 2025 | ||||||||
| Regulatory Exclusivity Use: | COMPETITIVE GENERIC THERAPY | ||||||||
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