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Generated: December 18, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 091656

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NDA 091656 describes OFLOXACIN, which is a drug marketed by Bedford, Akorn, Altaire Pharms Inc, Alvogen, Apotex Inc, Bausch And Lomb, Fdc Ltd, Hi Tech Pharma, Sandoz, Sandoz Inc, Cadila Pharms Ltd, Dr Reddys Labs Ltd, Larken Labs, Ranbaxy Labs Ltd, and Teva, and is included in twenty NDAs. It is available from thirty-three suppliers. Additional details are available on the OFLOXACIN profile page.

The generic ingredient in OFLOXACIN is ofloxacin. There are seventy-one drug master file entries for this compound. Thirty-four suppliers are listed for this compound. Additional details are available on the ofloxacin profile page.

Summary for 091656

Tradename:1
Applicant:1
Ingredient:1
Patents:0
Therapeutic Class:Antibacterials
Formulation / Manufacturing:see details

Pharmacology for NDA: 091656

Ingredient-typeQuinolones

Suppliers and Packaging for NDA: 091656

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
OFLOXACIN ofloxacin TABLET;ORAL 091656 ANDA Cadila Pharmaceuticals Limited 71209-001 71209-001-10 500 TABLET, FILM COATED in 1 BOTTLE (71209-001-10)
OFLOXACIN ofloxacin TABLET;ORAL 091656 ANDA Cadila Pharmaceuticals Limited 71209-001 71209-001-05 100 TABLET, FILM COATED in 1 BOTTLE (71209-001-05)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength200MG
Approval Date:Sep 18, 2014TE:ABRLD:No

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength300MG
Approval Date:Sep 18, 2014TE:ABRLD:No

Summary for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength400MG
Approval Date:Sep 18, 2014TE:ABRLD:No


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