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FLOXIN OTIC

NDA

OFLOXACIN | N020799 | DAIICHI PHARMACEUTICAL CORP

1 strength0 unique patents0 unique exclusivities

PTAB Proceedings

No IPR/PGR/CBM challenges found at the Patent Trial and Appeal Board

Patent Reexaminations

No ex parte or inter partes reexamination proceedings found at USPTO

Hatch-Waxman Litigation

Para IV certification filed but no ANDA patent litigation cases (NOS 835) matched from PACER. Litigation may be pending or filed under a different caption.

Citizen Petitions

No FDA citizen petitions matched from Regulations.gov

Clinical Trials

No clinical trials found on ClinicalTrials.gov for this drug

API Supply Chain5 active DMFs5 inactive

5 active API suppliers hold Drug Master Files for this ingredient.

QUIMICA SINTETICA SAOFLOXACIN

DMF 147672000

CAMBREX CHARLES CITY INCOFLOXACIN USP

DMF 149282000

NEULAND LABORATORIES LTDOFLOXACIN USP

DMF 154332001

MAHIMA LIFE SCIENCES PRIVATE LTDOFLOXACIN USP

DMF 278872013

TURTLE PHARMA PRIVATE LTDOFLOXACIN USP

DMF 332502018

DAIICHI SANKYO PROPHARMA CO LTDInactiveOFLOXACIN BULK PRODUCT

DMF 63511986

NORAMCO INCInactiveOFLOXACIN

DMF 109221994

SUN PHARMACEUTICAL INDUSTRIES LTDInactiveOFLOXACIN USP

DMF 142401999

CIPLA LTDInactiveOFLOXACIN USP

DMF 167532003

KUNSHAN DOUBLE CRANE PHARMACEUTICAL CO LTDInactiveOFLOXACIN

DMF 173082004

Source: FDA Drug Master Files (fda.gov). Type II API DMFs matched by ingredient.

Approval Letters

4 letters from Drugs@FDA

Date	Submission	Document
May 17, 2005	SUPPL -16	View Letter (PDF)
Feb 25, 2004	SUPPL -15	View Letter (PDF)
Oct 9, 2003	SUPPL -6	View Letter (PDF)
Oct 9, 2003	SUPPL -12	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — 0.3% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RLD

0 patents0 exclusivities▴

SOLUTION/DROPS;OTIC | Approved: Dec 16, 1997

No patent or exclusivity listings for this strength.