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NDA

ZIPRASIDONE HYDROCHLORIDE | N021483 | PFIZER 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

No ANDA patent litigation cases (NOS 835) matched from PACER

Citizen Petitions

No FDA citizen petitions matched from Regulations.gov

Clinical Trials

No clinical trials found on ClinicalTrials.gov for this drug

API Supply Chain14 active DMFs6 inactive

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

DR REDDYS LABORATORIES LTDZIPRASIDONE HYDROCHLORIDE USP

DMF 179222004

APOTEX INCZIPRASIDONE HYDROCHLORIDE

DMF 180502005

LUPIN LTDZIPRASIDONE HYDROCHLORIDE USP

DMF 180552005

WOCKHARDT LTDZIPRASIDONE HYDROCHLORIDE MONOHYDRATE

DMF 195032006

ZYDUS LIFESCIENCES LTDZIPRASIDONE HYDROCHLORIDE MONOHYDRATE USP

DMF 207692007

APITORIA PHARMA PRIVATE LTDZIPRASIDONE HYDROCHLORIDE USP (NON-STERILE DRUG SUBSTANCE)

DMF 210122007

DR REDDYS LABORATORIES LTDZIPRASIDONE HYDROCHLORIDE MONOHYDRATE

DMF 211472007

MEGAFINE PHARMA P LTDZIPRASIDONE HYDROCHLORIDE MONOHYDRATE USP (NON STERILE DRUG SUBSTANCE)

DMF 237392010

JUBILANT PHARMOVA LTDZIPRASIDONE HYDROCHLORIDE USP

DMF 249552011

MACLEODS PHARMACEUTICALS LTDZIPRASIDONE HYDROCHLORIDE

DMF 250482011

AMINO CHEMICALS LTDZIPRASIDONE HYDROCHLORIDE MONOHYDRATE

DMF 272592013

RAKS PHARMA PVT LTDZIPRASIDONE HYDROCHLORIDE MONOHYDRATE, USP

DMF 311832016

APOTEX INCZIPRASIDONE HYDROCHLORIDE MONOHYDRATE USP

DMF 331732018

CHROMO LABORATORIES INDIA PRIVATE LTDZIPRASIDONE HYDROCHLORIDE USP

DMF 339912019

RANBAXY LABORATORIES LTDInactiveZIPRASIDONE HYDROCHLORIDE

DMF 180422005

CADILA HEALTHCARE LTDInactiveZIPRASIDONE HYDROCHLORIDE ANHYDROUS

DMF 189522005

TEVA PHARMACEUTICALS INDUSTRIES LTDInactiveZIPRASIDONE HYDROCHLORIDE

DMF 190052005

AMINO CHEMICALS LTDInactiveZIPRASIDONE HYDROCHLORIDE ANHYDROUS

DMF 201052006

WATSON PHARMA PRIVATE LTDInactiveZIPRASIDONE HYDROCHLORIDE MONOHYDRATE USP

DMF 243472010

QILU TIANHE PHARMACEUTICAL CO LTDInactiveZIPRASIDONE HYDROCHLORIDE (NON - STERILE API)

DMF 248372011

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

Approval Letters

9 letters from Drugs@FDA

Date	Submission	Document
Mar 2, 2017	SUPPL -15	View Letter (PDF)
Aug 24, 2015	SUPPL -14	View Letter (PDF)
Dec 11, 2014	SUPPL -13	View Letter (PDF)
Aug 16, 2013	SUPPL -10	View Letter (PDF)
Jul 5, 2013	SUPPL -7	View Letter (PDF)
Mar 5, 2013	SUPPL -9	View Letter (PDF)
Dec 7, 2010	SUPPL -5	View Letter (PDF)
Nov 24, 2009	SUPPL -3	View Letter (PDF)
Apr 5, 2006	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — EQ 10MG BASE/ML

0 patents0 exclusivities▴

SUSPENSION;ORAL | Approved: Mar 29, 2006

No patent or exclusivity listings for this strength.