Details for New Drug Application (NDA): 216501
NDA 216501 describes CIPROFLOXACIN AND DEXAMETHASONE, which is a drug marketed by Amneal, Dr Reddys, Sentiss, Sun Pharm, and Upsher Smith Labs, and is included in five NDAs. It is available from eleven suppliers. Additional details are available on the CIPROFLOXACIN AND DEXAMETHASONE profile page.
The generic ingredient in CIPROFLOXACIN AND DEXAMETHASONE is ciprofloxacin; dexamethasone. There is one drug master file entry for this compound. Twelve suppliers are listed for this compound. Additional details are available on the ciprofloxacin; dexamethasone profile page.
The generic ingredient in CIPROFLOXACIN AND DEXAMETHASONE is ciprofloxacin; dexamethasone. There is one drug master file entry for this compound. Twelve suppliers are listed for this compound. Additional details are available on the ciprofloxacin; dexamethasone profile page.
Summary for 216501
| Tradename: | CIPROFLOXACIN AND DEXAMETHASONE |
| Applicant: | Amneal |
| Ingredient: | ciprofloxacin; dexamethasone |
| Patents: | 0 |
Pharmacology for NDA: 216501
| Mechanism of Action | Corticosteroid Hormone Receptor Agonists Cytochrome P450 1A2 Inhibitors |
Suppliers and Packaging for NDA: 216501
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| CIPROFLOXACIN AND DEXAMETHASONE | ciprofloxacin; dexamethasone | SUSPENSION/DROPS;OTIC | 216501 | ANDA | Amneal Pharmaceuticals of New York LLC | 53746-831 | 53746-831-53 | 1 BOTTLE, PLASTIC in 1 CARTON (53746-831-53) / 7.5 mL in 1 BOTTLE, PLASTIC |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | SUSPENSION/DROPS;OTIC | Strength | 0.3%;0.1% | ||||
| Approval Date: | Mar 22, 2024 | TE: | AB | RLD: | No | ||||
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