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PROCOMP

ANDA

PROCHLORPERAZINE MALEATE | A040268 | JUBILANT CADISTA PHARMACEUTICALS INC

2 strengths0 unique patents0 unique exclusivities

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

1 letter from Drugs@FDA

Date	Submission	Document
May 15, 2025	SUPPL -33	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (2)

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#001 — EQ 5MG BASE

0 patents0 exclusivities▴

TABLET;ORAL | Approved: Feb 27, 1998

No patent or exclusivity listings for this strength.

#002 — EQ 10MG BASE

0 patents0 exclusivities▾

TABLET;ORAL | Approved: Feb 27, 1998