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COMPAZINE

NDA

PROCHLORPERAZINE EDISYLATE | N010742 | GLAXOSMITHKLINE

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 Chain4 active DMFs4 inactive

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

TRIFARMA SPAPROCHLORPERAZINE EDISYLATE USP

DMF 160552002

EMCURE PHARMACEUTICALS LTDPROCHLORPERAZINE EDISYLATE USP

DMF 311762016

BIOPHORE INDIA PHARMACEUTICALS PVT LTDPROCHLORPERAZINE EDISYLATE

DMF 321782017

RAKS PHARMA PVT LTDPROCHLORPERAZINE EDISYLATE USP

DMF 336932019

SANOFI INCInactivePROCHLORPERAZINE EDISYLATE

DMF 35451979

NV ORGANONInactivePROCHLORPERAZINE EDISYLATE

DMF 54251984

AMERICAN CHEMICAL INDUSTRIAL CORPInactivePROCHLORPERAZINE EDISYLATE USP XXI

DMF 59411985

JOHNSON MATTHEY INCInactivePROCHLORPERAZINE EDISYLATE

DMF 102131993

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

Approval Letters

1 letter from Drugs@FDA

Date	Submission	Document
Apr 3, 2001	SUPPL -65	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#002 — EQ 5MG BASE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RLD

0 patents0 exclusivities▴

INJECTABLE;INJECTION | Approved: Approved Prior to Jan 1, 1982

No patent or exclusivity listings for this strength.