Viewing data from:

CHLORTHALIDONE

ANDA

CHLORTHALIDONE | A088651 | COSETTE PHARMACEUTICALS NC LABORATORIES LLC

1 strength0 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 (1)

#001 — 50MG

0 patents0 exclusivities▴

TABLET;ORAL | Approved: May 30, 1985

No patent or exclusivity listings for this strength.

Change History (2)

Recent changes detected for this application.

MODIFIEDApplicant7/1/2026

Cosette Pharmaceuticals changed its registered applicant name from Cosette to Cosette Pharms NC for chlorthalidone NDA 088651.

Old: COSETTE

New: COSETTE PHARMS NC

MODIFIEDApplicant Full Name7/1/2026

Cosette Pharmaceuticals updated its legal entity name from Cosette Pharmaceuticals Inc to Cosette Pharmaceuticals NC Laboratories LLC for chlorthalidone NDA 088651.

Old: COSETTE PHARMACEUTICALS INC

New: COSETTE PHARMACEUTICALS NC LABORATORIES LLC