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Details for New Drug Application (NDA): 019537

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NDA 019537 describes CIPRO, which is a drug marketed by Bayer Hlthcare, Novartis Pharms Corp, Bayer Pharms, Hikma Farmaceutica, Hospira, Claris, Lupin Ltd, Teva Pharms Usa, Fresenius Kabi Usa, Bedford Labs, Dr Reddys Labs Ltd, Actavis Labs Fl Inc, Sandoz, Anchen Pharms, Mylan Pharms Inc, Taro, Mylan, Barr, Carlsbad, Pliva, Apotex Inc, Teva, Nostrum Labs, Idt Australia Ltd, Unique Pharm Labs, Sun Pharm Inds Ltd, Teligent Pharma Inc, Akorn Inc, Hikma, Aurobindo Pharma, Fdc Ltd, Watson Labs Inc, Rising Pharms Inc, Ivax Sub Teva Pharms, Watson Labs, Apotex, Pharmaforce, Bedford, Teva Pharms, Acs Dobfar Info Sa, and Baxter Hlthcare, and is included in fifty-five NDAs. It is available from one supplier. There are eight patents protecting this drug and two Paragraph IV challenges. Additional details are available on the CIPRO profile page.

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

Summary for NDA: 019537

Bayer Hlthcare
ciprofloxacin hydrochloride
Formulation / Manufacturing:see details

Pharmacology for NDA: 019537


Suppliers and Packaging for NDA: 019537

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ciprofloxacin hydrochloride
TABLET;ORAL 019537 NDA Bayer HealthCare Pharmaceuticals Inc. 50419-754 50419-754-01 100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (50419-754-01)
ciprofloxacin hydrochloride
TABLET;ORAL 019537 NDA Bayer HealthCare Pharmaceuticals Inc. 50419-758 50419-758-01 100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (50419-758-01)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 100MG BASE
Approval Date:Apr 8, 1996TE:ABRLD:No

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 250MG BASE
Approval Date:Oct 22, 1987TE:ABRLD:No

Summary for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 500MG BASE
Approval Date:Oct 22, 1987TE:ABRLD:Yes

Expired Orange Book Patents for NDA: 019537

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Bayer Hlthcare
ciprofloxacin hydrochloride
TABLET;ORAL019537-003Oct 22, 19874,670,444*PED► subscribe
Bayer Hlthcare
ciprofloxacin hydrochloride
TABLET;ORAL019537-001Apr 8, 19964,670,444*PED► subscribe
Bayer Hlthcare
ciprofloxacin hydrochloride
TABLET;ORAL019537-004Oct 22, 19875,286,754*PED► subscribe
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