Details for New Drug Application (NDA): 078183
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NDA 078183 describes CIPROFLOXACIN EXTENDED RELEASE, which is a drug marketed by Ani Pharms, Dr Reddys Labs Ltd, Endo Operations, Fosun Pharma, and Rising, and is included in five NDAs. Additional details are available on the CIPROFLOXACIN EXTENDED RELEASE profile page.
The generic ingredient in CIPROFLOXACIN EXTENDED RELEASE is ciprofloxacin; ciprofloxacin hydrochloride. There are thirty-four drug master file entries for this compound. Additional details are available on the ciprofloxacin; ciprofloxacin hydrochloride profile page.
The generic ingredient in CIPROFLOXACIN EXTENDED RELEASE is ciprofloxacin; ciprofloxacin hydrochloride. There are thirty-four drug master file entries for this compound. Additional details are available on the ciprofloxacin; ciprofloxacin hydrochloride profile page.
Summary for 078183
| Tradename: | CIPROFLOXACIN EXTENDED RELEASE |
| Applicant: | Rising |
| Ingredient: | ciprofloxacin; ciprofloxacin hydrochloride |
| Patents: | 0 |
Profile for product number 001
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET, EXTENDED RELEASE;ORAL | Strength | 212.6MG;EQ 287.5MG BASE | ||||
| Approval Date: | Mar 22, 2007 | TE: | RLD: | No | |||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET, EXTENDED RELEASE;ORAL | Strength | 425.2MG;EQ 574.9MG BASE | ||||
| Approval Date: | Mar 22, 2007 | TE: | RLD: | No | |||||
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