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COMPAZINE

NDA

PROCHLORPERAZINE MALEATE | N010571 | GLAXOSMITHKLINE

3 strengths0 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 Chain3 active DMFs4 inactive

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

TRIFARMA SPAPROCHLORPERAZINE MALEATE

DMF 23681974

BIOPHORE INDIA PHARMACEUTICALS PVT LTDPROCHLORPERAZINE MALEATE

DMF 318422017

RAKS PHARMA PVT LTDPROCHLORPERAZINE MALEATE USP

DMF 361732021

INDUSTRIA CHIMICA MILANESE SPAInactivePROCHLORPERAZINE MALEATE

DMF 4681962

PHENCHEM INDUSTRIES LTDInactivePROCHLORPERAZINE MALEATE

DMF 25931976

CYCLO PRODUCTS INCInactivePROCHLORPERAZINE MALEATE U.S.P.

DMF 30781977

EGIS PHARMACEUTICALS PRIVATE LTDInactivePROCHLORPERAZINE MALEATE

DMF 93641991

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

Approval Letters

2 letters from Drugs@FDA

Date	Submission	Document
Aug 8, 2005	SUPPL -96	View Letter (PDF)
Apr 3, 2001	SUPPL -95	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (3)

Sort:

#001 — EQ 5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RLD

0 patents0 exclusivities▴

TABLET;ORAL | Approved: Approved Prior to Jan 1, 1982

No patent or exclusivity listings for this strength.

#002 — EQ 10MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RLD

0 patents0 exclusivities▾

TABLET;ORAL | Approved: Approved Prior to Jan 1, 1982

#003 — EQ 25MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RLD

0 patents0 exclusivities▾

TABLET;ORAL | Approved: Approved Prior to Jan 1, 1982