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Generated: November 20, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 020780

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NDA 020780 describes CIPRO, which is a drug marketed by Bayer Hlthcare, Novartis Pharms Corp, Bayer Pharms, Lupin Ltd, Baxter Hlthcare Corp, Bedford Labs, Fresenius Kabi Usa, Hikma Farmaceutica, Hospira, Teva Pharms Usa, Actavis Labs Fl Inc, Anchen Pharms, Dr Reddys Labs Ltd, Fosun Pharma, Mylan Pharms Inc, Akorn Inc, Altaire Pharms Inc, Amring Pharms, Anda Repository, Apotex Inc, Fdc Ltd, Teligent, Watson Labs Inc, Ani Pharms Inc, Apotex, Aurobindo Pharma, Barr, Carlsbad, Hikma, Ivax Sub Teva Pharms, Mylan, Nostrum Labs, Pliva, Sun Pharm Inds Ltd, Taro Pharm, Teva, Unique Pharm Labs, Watson Labs, Yiling Pharm Ltd, Baxter Hlthcare, Bedford, Inforlife, and Teva Pharms, and is included in fifty-seven 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 020780
Tradename:CIPRO
Applicant:Bayer Hlthcare
Ingredient:ciprofloxacin
Patents:0
Formulation / Manufacturing:see details
Medical Subject Heading (MeSH) Categories for 020780
Suppliers and Packaging for NDA: 020780
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
CIPRO ciprofloxacin FOR SUSPENSION;ORAL 020780 NDA Bayer HealthCare Pharmaceuticals Inc. 50419-773 50419-773-01 1 KIT in 1 KIT (50419-773-01) * 100 mL in 1 BOTTLE, GLASS * 100 mL in 1 BOTTLE, GLASS
CIPRO ciprofloxacin FOR SUSPENSION;ORAL 020780 NDA Bayer HealthCare Pharmaceuticals Inc. 50419-777 50419-777-01 1 KIT in 1 KIT (50419-777-01) * 100 mL in 1 BOTTLE, GLASS * 100 mL in 1 BOTTLE, PLASTIC

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:FOR SUSPENSION;ORALStrength250MG/5ML
Approval Date:Sep 26, 1997TE:ABRLD:Yes

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:FOR SUSPENSION;ORALStrength500MG/5ML
Approval Date:Sep 26, 1997TE:ABRLD:Yes

Expired US Patents for NDA 020780

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Bayer Hlthcare CIPRO ciprofloxacin FOR SUSPENSION;ORAL 020780-001 Sep 26, 1997 ➤ Sign Up ➤ Sign Up
Bayer Hlthcare CIPRO ciprofloxacin FOR SUSPENSION;ORAL 020780-002 Sep 26, 1997 ➤ Sign Up ➤ Sign Up
Bayer Hlthcare CIPRO ciprofloxacin FOR SUSPENSION;ORAL 020780-002 Sep 26, 1997 ➤ Sign Up ➤ Sign Up
Bayer Hlthcare CIPRO ciprofloxacin FOR SUSPENSION;ORAL 020780-002 Sep 26, 1997 ➤ Sign Up ➤ Sign Up
Bayer Hlthcare CIPRO ciprofloxacin FOR SUSPENSION;ORAL 020780-001 Sep 26, 1997 ➤ Sign Up ➤ Sign Up
Bayer Hlthcare CIPRO ciprofloxacin FOR SUSPENSION;ORAL 020780-001 Sep 26, 1997 ➤ Sign Up ➤ Sign Up
Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration

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