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ELESTAT

NDA

EPINASTINE HYDROCHLORIDE | N021565 | 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

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 DMFs1 inactive

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

BOEHRINGER INGELHEIM PHARMA GMBH AND CO KGEPINASTINE HYDROCHLORIDE

DMF 150032000

ICROM SRLEPINASTINE HYDROCHLORIDE

DMF 218302008

TRIFARMA SPAEPINASTINE HYDROCHLORIDE

DMF 218512008

SUN PHARMACEUTICAL INDUSTRIES LTDEPINASTINE HYDROCHLORIDE

DMF 228542009

WUHAN CALMLAND PHARMACEUTICALS CO LTDEPINASTINE HYDROCHLORIDE

DMF 402562024

EXCELLA GMBH AND CO KGInactiveEPINASTINE HYDROCHLORIDE

DMF 209932007

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

Approval Letters

3 letters from Drugs@FDA

Date	Submission	Document
Dec 22, 2011	SUPPL -6	View Letter (PDF)
Aug 19, 2005	SUPPL -5	View Letter (PDF)
Oct 14, 2003	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — 0.05% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RLD

0 patents0 exclusivities▴

SOLUTION/DROPS;OPHTHALMIC | Approved: Oct 16, 2003

No patent or exclusivity listings for this strength.