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Details for New Drug Application (NDA): 021473

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NDA 021473 describes CIPRO XR, which is a drug marketed by Bayer Hlthcare and is included in one NDA. It is available from one supplier. There are two patents protecting this drug. Additional details are available on the CIPRO XR profile page.

The generic ingredient in CIPRO XR is ciprofloxacin; ciprofloxacin hydrochloride. There are thirty-one drug master file entries for this compound. Five suppliers are listed for this compound. Additional details are available on the ciprofloxacin; ciprofloxacin hydrochloride profile page.

Summary for NDA: 021473

Tradename:
CIPRO XR
Applicant:
Bayer Hlthcare
Ingredient:
ciprofloxacin; ciprofloxacin hydrochloride
Patents:2
Formulation / Manufacturing:see details

Pharmacology for NDA: 021473

Ingredient-typeQuinolones

Suppliers and Packaging for NDA: 021473

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
CIPRO XR
ciprofloxacin; ciprofloxacin hydrochloride
TABLET, EXTENDED RELEASE;ORAL 021473 NDA Bayer HealthCare Pharmaceuticals Inc. 50419-788 50419-788-00 38220 TABLET, FILM COATED, EXTENDED RELEASE in 1 DRUM (50419-788-00)
CIPRO XR
ciprofloxacin; ciprofloxacin hydrochloride
TABLET, EXTENDED RELEASE;ORAL 021473 NDA Bayer HealthCare Pharmaceuticals Inc. 50419-788 50419-788-01 50 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (50419-788-01)

Summary for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:TABLET, EXTENDED RELEASE;ORALStrength212.6MG;EQ 287.5MG BASE
Approval Date:Dec 13, 2002TE:RLD:No
Patent:7,709,022*PEDPatent Expiration:Dec 23, 2021Product Flag?Substance Flag?Delist Request?Y
Patent:8,187,632*PEDPatent Expiration:Dec 23, 2021Product Flag?Substance Flag?Delist Request?Y

Summary for product number 002

Active Rx/OTC/Discontinued:DISCNDosage:TABLET, EXTENDED RELEASE;ORALStrength425.2MG;EQ 574.9MG BASE
Approval Date:Aug 28, 2003TE:RLD:No
Patent:7,709,022*PEDPatent Expiration:Dec 23, 2021Product Flag?Substance Flag?Delist Request?Y

Expired Orange Book Patents for NDA: 021473

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Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Bayer Hlthcare
CIPRO XR
ciprofloxacin; ciprofloxacin hydrochloride
TABLET, EXTENDED RELEASE;ORAL021473-001Dec 13, 20024,670,444*PED► subscribe
Bayer Hlthcare
CIPRO XR
ciprofloxacin; ciprofloxacin hydrochloride
TABLET, EXTENDED RELEASE;ORAL021473-002Aug 28, 20034,670,444*PED► subscribe
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