Viewing data from:

THORAZINE

NDA

CHLORPROMAZINE HYDROCHLORIDE | N011120 | GLAXOSMITHKLINE

5 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 Chain9 active DMFs6 inactive

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

SANOFI WINTHROP INDUSTRIECHLORPROMAZINE HYDROCHLORIDE

DMF 15161970

RL FINE CHEM PVT LTDCHLORPROMAZINE HYDROCHLORIDE

DMF 307312017

BIOPHORE INDIA PHARMACEUTICALS PVT LTDCHLORPROMAZINE HYDROCHLORIDE

DMF 314792017

ENALTEC LABS PRIVATE LTDCHLORPROMAZINE HYDROCHLORIDE USP

DMF 320142018

RAKS PHARMA PVT LTDCHLORPROMAZINE HYDROCHLORIDE USP

DMF 329202018

MAITHRI LABORATORIES PRIVATE LTDCHLORPROMAZINE HYDROCHLORIDE USP

DMF 333532018

SOLARA ACTIVE PHARMA SCIENCES LTDCHLORPROMAZINE HYDROCHLORIDE USP

DMF 335542019

EMCURE PHARMACEUTICALS LTDCHLORPROMAZINE HYDROCHLORIDE USP

DMF 342482019

DASAMI LAB PRIVATE LTDCHLORPROMAZINE HYDROCHLORIDE USP

DMF 351892020

INDUSTRIA CHIMICA MILANESE SPAInactiveCHLORPROMAZINE HYDROCHLORIDE

DMF 4691962

JUNICE LABS INCInactiveCHLORPROMAZINE HYDROCHLORIDE U.S.P.

DMF 9131965

PHENCHEM INDUSTRIES LTDInactiveCHLORPROMAZINE HYDROCHLORIDE

DMF 21041973

GYMA LABORATORIES AMERICA INCInactiveCHLORPROMAZINE HYDROCHLORIDE

DMF 21351973

H REISMAN CORPInactiveCHLORPROMAZINE HYDROCHLORIDE (BULK)

DMF 22701974

ZAKLADY FARMACEUTYCZNE POLPHARMA SAInactiveCHLORPROMAZINE HYDROCHLORIDE

DMF 332032018

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 -86	View Letter (PDF)

Source: Drugs@FDA application documents.