Viewing data from:

CHLORPROMAZINE HYDROCHLORIDE

ANDA

CHLORPROMAZINE HYDROCHLORIDE | A216678 | RUBICON RESEARCH LTD

2 strengths0 unique patents0 unique exclusivities

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.

Products (2)

Sort:

#001 — 30MG/ML

0 patents0 exclusivities▴

CONCENTRATE;ORAL | Approved: Oct 10, 2025

No patent or exclusivity listings for this strength.

#002 — 100MG/ML

0 patents0 exclusivities▾

CONCENTRATE;ORAL | Approved: Oct 10, 2025

Change History (4)

Recent changes detected for this application.

MODIFIEDApplicant7/1/2026

Applicant name for chlorpromazine hydrochloride (NDA 216678, supplement 002) changed from RUBICON to RUBICON RESEARCH.

Old: RUBICON

New: RUBICON RESEARCH

MODIFIEDApplicant7/1/2026

Applicant name for chlorpromazine hydrochloride (NDA 216678) updated from RUBICON to RUBICON RESEARCH.

Old: RUBICON

New: RUBICON RESEARCH

MODIFIEDApplicant Full Name7/1/2026

Rubicon Research Private Ltd updated its registered applicant name to Rubicon Research Ltd for the chlorpromazine hydrochloride NDA 216678.

Old: RUBICON RESEARCH PRIVATE LTD

New: RUBICON RESEARCH LTD

MODIFIEDApplicant Full Name7/1/2026

Rubicon Research Private Ltd updated its legal entity name to Rubicon Research Ltd for the chlorpromazine hydrochloride NDA 216678.

Old: RUBICON RESEARCH PRIVATE LTD

New: RUBICON RESEARCH LTD