Details for New Drug Application (NDA): 216501
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NDA 216501 describes CIPROFLOXACIN; DEXAMETHASONE, which is a drug marketed by Amneal and is included in one NDA. It is available from one supplier. Additional details are available on the CIPROFLOXACIN; DEXAMETHASONE profile page.
The generic ingredient in CIPROFLOXACIN; DEXAMETHASONE is ciprofloxacin; dexamethasone. There are thirty-four drug master file entries for this compound. Ten suppliers are listed for this compound. Additional details are available on the ciprofloxacin; dexamethasone profile page.
The generic ingredient in CIPROFLOXACIN; DEXAMETHASONE is ciprofloxacin; dexamethasone. There are thirty-four drug master file entries for this compound. Ten suppliers are listed for this compound. Additional details are available on the ciprofloxacin; dexamethasone profile page.
Summary for 216501
| Tradename: | CIPROFLOXACIN; 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; 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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