Details for New Drug Application (NDA): 021918
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NDA 021918 describes CETRAXAL, which is a drug marketed by Key Therap and is included in one NDA. It is available from two suppliers. Additional details are available on the CETRAXAL profile page.
The generic ingredient in CETRAXAL is ciprofloxacin hydrochloride. There are thirty-four drug master file entries for this compound. Fifty-six suppliers are listed for this compound. Additional details are available on the ciprofloxacin hydrochloride profile page.
The generic ingredient in CETRAXAL is ciprofloxacin hydrochloride. There are thirty-four drug master file entries for this compound. Fifty-six suppliers are listed for this compound. Additional details are available on the ciprofloxacin hydrochloride profile page.
Summary for 021918
| Tradename: | CETRAXAL |
| Applicant: | Key Therap |
| Ingredient: | ciprofloxacin hydrochloride |
| Patents: | 0 |
Pharmacology for NDA: 021918
| Mechanism of Action | Cytochrome P450 1A2 Inhibitors |
Suppliers and Packaging for NDA: 021918
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| CETRAXAL | ciprofloxacin hydrochloride | SOLUTION/DROPS;OTIC | 021918 | NDA | Xspire Pharma, Llc | 42195-550 | 42195-550-14 | 14 CONTAINER in 1 CARTON (42195-550-14) / .25 mL in 1 CONTAINER |
| CETRAXAL | ciprofloxacin hydrochloride | SOLUTION/DROPS;OTIC | 021918 | NDA | Wraser Llc | 66992-450 | 66992-450-14 | 14 CONTAINER in 1 CARTON (66992-450-14) / .25 mL in 1 CONTAINER |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | SOLUTION/DROPS;OTIC | Strength | EQ 0.2% BASE | ||||
| Approval Date: | May 1, 2009 | TE: | RLD: | Yes | |||||
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