Viewing data from:

CHLORTHALIDONE

ANDA

CHLORTHALIDONE | A206904 | INGENUS PHARMACEUTICALS LLC

2 strengths0 unique patents0 unique exclusivities

API Supply Chain15 active DMFs11 inactive

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

CURIA ITALY SRLCHLORTHALIDONE USP-EP

DMF 24381975

IPCA LABORATORIES LTDCHLORTHALIDONE USP

DMF 178082004

IPCA LABORATORIES LTDCHLORTHALIDONE USP (CT6 PROCESS)

DMF 275792013

AMOLI ORGANICS (A DIVISION OF UMEDICA LABORATORIES PVT LTD)CHLORTHALIDONE USP

DMF 305512016

UNICHEM LABORATORIES LTDCHLORTHALIDONE USP

DMF 320372017

MACLEODS PHARMACEUTICALS LTDCHLORTHALIDONE

DMF 322072017

MATRIX PHARMACORP PRIVATE LTDCHLORTHALIDONE USP

DMF 322912017

SOLARA ACTIVE PHARMA SCIENCES LTDCHLORTHALIDONE USP

DMF 324122018

MAITHRI DRUGS PRIVATE LTDCHLORTHALIDONE USP

DMF 326412018

CHROMO LABORATORIES INDIA PRIVATE LTDCHLORTHALIDONE USP

DMF 330712018

ZYDUS LIFESCIENCES LTDCHLORTHALIDONE USP

DMF 334322019

MENADIONA SLCHLORTHALIDONE

DMF 344092020

HONOUR LAB LTDCHLORTHALIDONE

DMF 352362021

CTX LIFESCIENCES PVT LTDCHLORTHALIDONE USP

DMF 391422023

MSN LIFE SCIENCES PRIVATE LTDCHLORTHALIDONE USP

DMF 405152024

INDUSTRIE CHIMICHE FARMACEUTICHE ITALIANE SPAInactiveCHLORTHALIDONE

DMF 28141976

FARCHEMIA SRLInactiveCHLORTHALIDONE

DMF 34451977

ACIC LTDInactiveCHLORTHALIDONE USP

DMF 34741979

BIDACHEM SPAInactiveCHLORTHALIDONE U.S.P.

DMF 46011982

ORION CORP LTDInactiveCHLORTHALIDONE USP XX AND BP 80

DMF 46821982

E MERCKInactiveCHLORTHALIDONE USP

DMF 50161983

TEVA PHARMACEUTICAL INDUSTRIES LTDInactiveCHLORTHALIDONE

DMF 51041983

SANDOZ LTD PHARMACEUTICAL DIV CHEMICAL DEVELOPMENTInactiveCHLORTHALIDONE

DMF 51091983

CIBA GEIGY LTDInactiveCHLORTHALIDONE USP

DMF 69101987

AInactiveCHLORTHALIDONE

DMF 82041989

AMOLI ORGANICS PVT LTDInactiveCHLORTHALIDONE USP

DMF 266482012

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

Products (2)

Sort:

#001 — 25MG

0 patents0 exclusivities▴

TABLET;ORAL | Approved: Mar 30, 2017

No patent or exclusivity listings for this strength.

#002 — 50MG

0 patents0 exclusivities▾

TABLET;ORAL | Approved: Mar 30, 2017

Change History (4)

Recent changes detected for this application.

MODIFIEDApplicant Full Name7/1/2026

Chlorthalidone NDA 206904 applicant changed from Novast Laboratories Ltd to Ingenus Pharmaceuticals LLC.

Old: NOVAST LABORATORIES LTD

New: INGENUS PHARMACEUTICALS LLC

MODIFIEDApplicant7/1/2026

Applicant for chlorthalidone NDA 206904 changed from Novast Labs to Ingenus Pharms LLC.

Old: NOVAST LABS

New: INGENUS PHARMS LLC