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Last Updated: November 21, 2024

Details for New Drug Application (NDA): 020087


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NDA 020087 describes FLOXIN IN DEXTROSE 5% IN PLASTIC CONTAINER, which is a drug marketed by Ortho Mcneil Pharm and is included in one NDA. Additional details are available on the FLOXIN IN DEXTROSE 5% IN PLASTIC CONTAINER profile page.

The generic ingredient in FLOXIN IN DEXTROSE 5% IN PLASTIC CONTAINER is ofloxacin. There are seventy-eight drug master file entries for this compound. Thirty-one suppliers are listed for this compound. Additional details are available on the ofloxacin profile page.
Summary for 020087

Profile for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:INJECTABLE;INJECTIONStrength400MG/100ML
Approval Date:Mar 31, 1992TE:RLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:DISCNDosage:INJECTABLE;INJECTIONStrength20MG/ML
Approval Date:Mar 31, 1992TE:RLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:DISCNDosage:INJECTABLE;INJECTIONStrength40MG/ML
Approval Date:Mar 31, 1992TE:RLD:No

Expired US Patents for NDA 020087

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Ortho Mcneil Pharm FLOXIN ofloxacin INJECTABLE;INJECTION 020087-002 Mar 31, 1992 ⤷  Sign Up ⤷  Sign Up
Ortho Mcneil Pharm FLOXIN IN DEXTROSE 5% IN PLASTIC CONTAINER ofloxacin INJECTABLE;INJECTION 020087-004 Mar 31, 1992 ⤷  Sign Up ⤷  Sign Up
Ortho Mcneil Pharm FLOXIN IN DEXTROSE 5% IN PLASTIC CONTAINER ofloxacin INJECTABLE;INJECTION 020087-005 Mar 31, 1992 ⤷  Sign Up ⤷  Sign Up
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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