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TRIOSTAT

NDA

LIOTHYRONINE SODIUM | N020105 | PH HEALTH LTD

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 Chain4 active DMFs1 inactive

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

PEPTIDO GMBHLIOTHYRONINE SODIUM

DMF 194672006

AZICO BIOPHORE INDIA PVT LTDLIOTHYRONINE SODIUM

DMF 309422016

VALARY LAB LTDLIOTHYRONINE SODIUM

DMF 389032023

MACLEODS PHARMACEUTICALS LTDLIOTHYRONINE SODIUM USP

DMF 424012025

SANDOZ GMBHInactiveLIOTHYRONINE SODIUM

DMF 71101987

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

Approval Letters

1 letter from Drugs@FDA

Date	Submission	Document
May 20, 2002	SUPPL -2	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — EQ 0.01MG BASE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RLD

0 patents0 exclusivities▴

INJECTABLE;INJECTION | Approved: Dec 31, 1991

No patent or exclusivity listings for this strength.