Viewing data from:

MICROZIDE

NDA

HYDROCHLOROTHIAZIDE | N020504 | TEVA BRANDED PHARMACEUTICAL PRODUCTS R AND D LLC

1 strength0 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 Chain18 active DMFs10 inactive

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

CAMBREX PROFARMACO MILANO SRLHYDROCHLOROTHIAZIDE

DMF 8811965

TAPI NL BVHYDROCHLOROTHIAZIDE

DMF 21151973

TAPI NL BVHYDROCHLOROTHIAZIDE

DMF 40281980

UNICHEM LABORATORIES LTDHYDROCHLOROTHIAZIDE USP

DMF 162782002

IPCA LABORATORIES LTDHYDROCHLOROTHIAZIDE USP

DMF 167072003

CHANGZHOU PHARMACEUTICAL FACTORYHYDROCHLOROTHIAZIDE

DMF 167502003

ZAKLADY FARMACEUTYCZNE POLPHARMA SAHYDROCHLOROTHIAZIDE

DMF 175992004

APITORIA PHARMA PRIVATE LTDHYDROCHLOROTHIAZIDE USP

DMF 177282004

IPCA LABORATORIES LTDHYDROCHLOROTHIAZIDE USP, PROCESS II

DMF 185632005

VALENS MOLECULES PRIVATE LTDHYDROCHLOROTHIAZIDE USP

DMF 197212006

UNICHEM LABORATORIES LTDHYDROCHLOROTHIAZIDE USP - PROCESS #2

DMF 205342007

CTX LIFE SCIENCES PVT LTDHYDROCHLOROTHIAZIDE USP

DMF 210392007

ZYDUS LIFESCIENCES LTDHYDROCHLOROTHIAZIDE USP

DMF 220272008

ALEMBIC PHARMACEUTICALS LTDHYDROCHLOROTHIAZIDE USP

DMF 222532008

ZHEJIANG HUAHAI PHARMACEUTICAL CO LTDHYDROCHLOROTHIAZIDE USP

DMF 225412008

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

DMF 258492012

MACLEODS PHARMACEUTICALS LTDHYDROCHLOROTHIAZIDE USP

DMF 339232019

LAURUS LABS LTDHYDROCHLOROTHIAZIDE USP

DMF 418892025

MICRO CHEMS LTDInactiveHYDROCHLOROTHIAZIDE USP

DMF 10591967

SMITH KLINE & FRENCH LABS DIV SMITHKLINE BECKMAN CORPInactiveHYDROCHLOROTHIAZIDE IN PHIL PA

DMF 44361982

LABORATORIOS JULIAN DE MEXICO SAInactiveHYDROCHLOROTHIAZIDE

DMF 44881982

ABBOTT LABORATORIES PHARMACEUTICAL PRODUCTS DIVInactiveHYDROCHLOROTHIAZIDE

DMF 45081982

CHANGZHOU PHARMACEUTICAL FACTORYInactiveHYDROCHLOROTHIAZIDE

DMF 49241983

CHINOIN PHARMACEUTCIAL AND CHEMICAL WORKS CO LTDInactiveHYDROCHLOROTHIAZIDE

DMF 51251983

SMITHKLINE AND BECKMAN INCInactiveHYDROCHLOROTHIAZIDE

DMF 56141984

ABBOTT LABORATORIES PHARMACEUTICAL PRODUCTS DIVInactiveHYDROCHLOROTHIAZIDE

DMF 60551985

UNICHEM LABORATORIES LTDInactiveHYDROCHLOROTHIAZIDE B.P.

DMF 62371985

SUZHOU LIXIN PHARMACEUTICAL CO LTDInactiveHYDROCHLOROTHIAZIDE

DMF 211812007

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

Approval Letters

2 letters from Drugs@FDA

Date	Submission	Document
Aug 21, 2020	SUPPL -26	View Letter (PDF)
Mar 21, 2011	SUPPL -18	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — 12.5MG

RLDAB

0 patents0 exclusivities▴

CAPSULE;ORAL | Approved: Dec 27, 1996

No patent or exclusivity listings for this strength.