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LOZOL

NDA

INDAPAMIDE | N018538 | SANOFI AVENTIS US LLC

2 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 Chain4 active DMFs4 inactive

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

BIOINDUSTRIA LABORATORIO ITALIANO MEDICINALI SPAINDAPAMIDE

DMF 90261991

QUIMICA SINTETICA SAINDAPAMIDE

DMF 90641991

INDUSTRIALE CHIMICA SRLINDAPAMIDE

DMF 216632008

BIOPHORE INDIA PHARMACEUTICALS PVT LTDINDAPAMIDE

DMF 386092023

ORIL INDUSTRIEInactiveINDAPAMIDE

DMF 85771990

FINE CHEMICALS CORPInactiveINDAPAMIDE

DMF 91491991

IPCA LABORATORIES LTDInactiveINDAPAMIDE USP

DMF 219752008

DISHMAN PHARMACEUTICALS AND CHEMICALS LTDInactiveINDAPAMIDE

DMF 223882009

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

Approval Letters

2 letters from Drugs@FDA

Date	Submission	Document
Mar 3, 2021	SUPPL -30	View Letter (PDF)
Nov 9, 2009	SUPPL -28	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (2)

Sort:

#001 — 2.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RLD

0 patents0 exclusivities▴

TABLET;ORAL | Approved: Jul 6, 1983

No patent or exclusivity listings for this strength.

#002 — 1.25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RLD

0 patents0 exclusivities▾

TABLET;ORAL | Approved: Apr 29, 1993