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PROSTIN E2

NDA

DINOPROSTONE | N017810 | 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 Chain6 active DMFs

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

PHARMACIA AND UPJOHN CO LLC WHOLLY OWNED SUB OF PFIZER INCDINOPROSTONE USP

DMF 52021984

KYOWA PHARMA CHEMICAL CO LTDDINOPROSTONE DRUG SUBSTANCE

DMF 112741994

EUROAPI HUNGARY LTDDINOPROSTONE (PROSTAGLANDIN E2)

DMF 115631995

CHIROGATE INTERNATIONAL INCDINOPROSTONE

DMF 379752023

KYOWA PHARMA CHEMICAL CO LTDDINOPROSTONE (IEDA) DRUG SUBSTANCE

DMF 413922025

TIEN (TIANJIN) PHARMACEUTICAL CO LTDDINOPROSTONE

DMF 422612025

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

Approval Letters

1 letter from Drugs@FDA

Date	Submission	Document
Jul 6, 2017	SUPPL -19	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — 20MG

RLD

0 patents0 exclusivities▴

SUPPOSITORY;VAGINAL | Approved: Approved Prior to Jan 1, 1982

No patent or exclusivity listings for this strength.