Details for New Drug Application (NDA): 021473
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The generic ingredient in CIPRO XR 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 021473
Tradename: | CIPRO XR |
Applicant: | Bayer Hlthcare |
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RELEASE;ORAL | Strength | 212.6MG;EQ 287.5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | ||||
Approval Date: | Dec 13, 2002 | 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RELEASE;ORAL | Strength | 425.2MG;EQ 574.9MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | ||||
Approval Date: | Aug 28, 2003 | TE: | RLD: | No |
Expired US Patents for NDA 021473
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Bayer Hlthcare | CIPRO XR | ciprofloxacin; ciprofloxacin hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 021473-002 | Aug 28, 2003 | ⤷ Sign Up | ⤷ Sign Up |
Bayer Hlthcare | CIPRO XR | ciprofloxacin; ciprofloxacin hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 021473-001 | Dec 13, 2002 | ⤷ Sign Up | ⤷ Sign Up |
Bayer Hlthcare | CIPRO XR | ciprofloxacin; ciprofloxacin hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 021473-001 | Dec 13, 2002 | ⤷ Sign Up | ⤷ Sign Up |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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