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NDA

GATIFLOXACIN | N021493 | ALLERGAN INC

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

1 case on OB patents from PACER

Case	Court	Filed	Status	Judge
Senju Pharmaceutical Co. Ltd. et al v. Apotex Inc. et al 1:2011cv01171 1 patentANDA 079084gatifloxacin	D. Del.	2011-11-28	Terminated 2012-09-17	—

Source: PACER. NOS 835 (Patent - Abbreviated New Drug Application).

Citizen Petitions

No FDA citizen petitions matched from Regulations.gov

Clinical Trials

No clinical trials found on ClinicalTrials.gov for this drug

API Supply Chain7 active DMFs7 inactive

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

KYORIN PHARMACEUTICAL CO LTDGATIFLOXACIN DRUG SUBSTANCE

DMF 155972001

DR REDDYS LABORATORIES LTDGATIFLOXACIN ANHYDROUS

DMF 170122003

MATRIX PHARMACORP PRIVATE LTDGATIFLOXACIN

DMF 170132003

APOTEX PHARMACHEM INDIA PVT LTDGATIFLOXACIN HEMIHYDRATE

DMF 206852007

LUPIN LTDGATIFLOXACIN

DMF 235522010

APITORIA PHARMA PRIVATE LTDGATIFLOXACIN HEMIHYDRATE (NON-STERILE DRUG SUBSTANCE)

DMF 264522012

STHREE CHEMICALS PRIVATE LTDGATIFLOXACIN SESQUIHYDRATE

DMF 407522024

KYORIN PHARMACEUTICAL CO LTDInactiveGATIFLOXACIN

DMF 139021998

TEVA GROUPInactiveGATIFLOXACIN

DMF 169652003

CADILA HEALTHCARE LTDInactiveGATIFLOXACIN ANHYDROUS

DMF 170022003

CADILA HEALTHCARE LTDInactiveGATIFLOXACIN SESQUIHYDRATE

DMF 170922004

HETERO DRUGS LTDInactiveGATIFLOXACIN HEMIHYDRATE

DMF 171102004

UQUIFA MEXICO SA DE CVInactiveGATIFLOXACIN HEMIHYDRATE

DMF 178222004

SIGNA SA DE CVInactiveGATIFLOXACIN HEMIHYDRATE

DMF 309992016

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

Approval Letters

5 letters from Drugs@FDA

Date	Submission	Document
Mar 24, 2017	SUPPL -11	View Letter (PDF)
May 22, 2015	SUPPL -10	View Letter (PDF)
Jun 21, 2005	SUPPL -6	View Letter (PDF)
Jun 21, 2005	SUPPL -7	View Letter (PDF)
Apr 1, 2003	ORIG -1	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#001 — 0.3% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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;OPHTHALMIC | Approved: Mar 28, 2003

No patent or exclusivity listings for this strength.