Details for New Drug Application (NDA): 077568
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NDA 077568 describes CIPROFLOXACIN HYDROCHLORIDE, which is a drug marketed by Altaire Pharms Inc, Amring Pharms, Fdc Ltd, Rising, Rubicon, Sciegen Pharms Inc, The J Molner, Watson Labs Inc, 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, and Yiling, and is included in twenty-seven NDAs. It is available from fifty-one suppliers. Additional details are available on the CIPROFLOXACIN HYDROCHLORIDE profile page.
The generic ingredient in CIPROFLOXACIN HYDROCHLORIDE 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 CIPROFLOXACIN HYDROCHLORIDE 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 077568
| Tradename: | CIPROFLOXACIN HYDROCHLORIDE |
| Applicant: | Fdc Ltd |
| Ingredient: | ciprofloxacin hydrochloride |
| Patents: | 0 |
Pharmacology for NDA: 077568
| Mechanism of Action | Cytochrome P450 1A2 Inhibitors |
Suppliers and Packaging for NDA: 077568
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| CIPROFLOXACIN HYDROCHLORIDE | ciprofloxacin hydrochloride | SOLUTION/DROPS;OPHTHALMIC | 077568 | ANDA | medsource pharmaceuticals | 45865-994 | 45865-994-01 | 1 BOTTLE, PLASTIC in 1 CARTON (45865-994-01) / 2.5 mL in 1 BOTTLE, PLASTIC |
| CIPROFLOXACIN HYDROCHLORIDE | ciprofloxacin hydrochloride | SOLUTION/DROPS;OPHTHALMIC | 077568 | ANDA | A-S Medication Solutions | 50090-4217 | 50090-4217-0 | 1 BOTTLE, PLASTIC in 1 CARTON (50090-4217-0) / 5 mL in 1 BOTTLE, PLASTIC |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | SOLUTION/DROPS;OPHTHALMIC | Strength | EQ 0.3% BASE | ||||
| Approval Date: | Jun 30, 2008 | TE: | AT | RLD: | No | ||||
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