Details for New Drug Application (NDA): 077689
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The generic ingredient in CIPROFLOXACIN HYDROCHLORIDE is ciprofloxacin hydrochloride. There are thirty-four drug master file entries for this compound. Fifty-two suppliers are listed for this compound. Additional details are available on the ciprofloxacin hydrochloride profile page.
Summary for 077689
Tradename: | CIPROFLOXACIN HYDROCHLORIDE |
Applicant: | Rising |
Ingredient: | ciprofloxacin hydrochloride |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Pharmacology for NDA: 077689
Mechanism of Action | Cytochrome P450 1A2 Inhibitors |
Suppliers and Packaging for NDA: 077689
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
CIPROFLOXACIN HYDROCHLORIDE | ciprofloxacin hydrochloride | SOLUTION/DROPS;OPHTHALMIC | 077689 | ANDA | Medsource Pharmaceuticals | 45865-721 | 45865-721-01 | 5 mL in 1 BOTTLE (45865-721-01) |
CIPROFLOXACIN HYDROCHLORIDE | ciprofloxacin hydrochloride | SOLUTION/DROPS;OPHTHALMIC | 077689 | ANDA | RPK Pharmaceuticals, Inc. | 53002-1320 | 53002-1320-1 | 2.5 mL in 1 BOTTLE, DROPPER (53002-1320-1) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | SOLUTION/DROPS;OPHTHALMIC | Strength | EQ 0.3% BASE | ||||
Approval Date: | Dec 13, 2006 | TE: | AT | RLD: | No |
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