Details for New Drug Application (NDA): 077859
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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 077859
Tradename: | CIPROFLOXACIN HYDROCHLORIDE |
Applicant: | Aurobindo Pharma |
Ingredient: | ciprofloxacin hydrochloride |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Pharmacology for NDA: 077859
Mechanism of Action | Cytochrome P450 1A2 Inhibitors |
Suppliers and Packaging for NDA: 077859
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
CIPROFLOXACIN HYDROCHLORIDE | ciprofloxacin hydrochloride | TABLET;ORAL | 077859 | ANDA | NCS HealthCare of KY, LLC dba Vangard Labs | 0615-8482 | 0615-8482-14 | 14 TABLET, FILM COATED in 1 BLISTER PACK (0615-8482-14) |
CIPROFLOXACIN HYDROCHLORIDE | ciprofloxacin hydrochloride | TABLET;ORAL | 077859 | ANDA | NCS HealthCare of KY, LLC dba Vangard Labs | 0615-8482 | 0615-8482-20 | 20 TABLET, FILM COATED in 1 BLISTER PACK (0615-8482-20) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | EQ 250MG BASE | ||||
Approval Date: | Apr 26, 2007 | TE: | AB | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | EQ 500MG BASE | ||||
Approval Date: | Apr 26, 2007 | TE: | AB | RLD: | No |
Profile for product number 003
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | EQ 750MG BASE | ||||
Approval Date: | Apr 26, 2007 | TE: | AB | RLD: | No |
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