Details for New Drug Application (NDA): 076558
✉ Email this page to a colleague
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 076558
Tradename: | CIPROFLOXACIN HYDROCHLORIDE |
Applicant: | Hikma |
Ingredient: | ciprofloxacin hydrochloride |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Pharmacology for NDA: 076558
Mechanism of Action | Cytochrome P450 1A2 Inhibitors |
Suppliers and Packaging for NDA: 076558
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
CIPROFLOXACIN HYDROCHLORIDE | ciprofloxacin hydrochloride | TABLET;ORAL | 076558 | ANDA | Hikma Pharmaceuticals USA Inc. | 0143-9927 | 0143-9927-01 | 100 TABLET, FILM COATED in 1 BOTTLE (0143-9927-01) |
CIPROFLOXACIN HYDROCHLORIDE | ciprofloxacin hydrochloride | TABLET;ORAL | 076558 | ANDA | Hikma Pharmaceuticals USA Inc. | 0143-9927 | 0143-9927-05 | 500 TABLET, FILM COATED in 1 BOTTLE (0143-9927-05) |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | EQ 250MG BASE | ||||
Approval Date: | Jun 9, 2004 | TE: | AB | RLD: | No |
Profile for product number 003
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | EQ 500MG BASE | ||||
Approval Date: | Jun 9, 2004 | TE: | AB | RLD: | No |
Profile for product number 004
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | EQ 750MG BASE | ||||
Approval Date: | Jun 9, 2004 | TE: | AB | RLD: | No |
Complete Access Available with Subscription