Details for New Drug Application (NDA): 075939
✉ 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 075939
Tradename: | CIPROFLOXACIN HYDROCHLORIDE |
Applicant: | Amneal |
Ingredient: | ciprofloxacin hydrochloride |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Pharmacology for NDA: 075939
Mechanism of Action | Cytochrome P450 1A2 Inhibitors |
Suppliers and Packaging for NDA: 075939
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
CIPROFLOXACIN HYDROCHLORIDE | ciprofloxacin hydrochloride | TABLET;ORAL | 075939 | ANDA | Amneal Pharmaceuticals NY LLC | 69238-2431 | 69238-2431-1 | 100 TABLET, FILM COATED in 1 BOTTLE (69238-2431-1) |
CIPROFLOXACIN HYDROCHLORIDE | ciprofloxacin hydrochloride | TABLET;ORAL | 075939 | ANDA | Amneal Pharmaceuticals NY LLC | 69238-2432 | 69238-2432-1 | 100 TABLET, FILM COATED in 1 BOTTLE (69238-2432-1) |
Profile for product number 001
Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET;ORAL | Strength | EQ 100MG BASE | ||||
Approval Date: | Mar 3, 2005 | TE: | RLD: | No |
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 |
Complete Access Available with Subscription