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ESKALITH

NDA

LITHIUM CARBONATE | N016860 | NOVEN THERAPEUTICS 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 Chain10 active DMFs4 inactive

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

LIVENT USA CORPLITHIUM CARBONATE

DMF 12411968

ALBEMARLE CORPLITHIUM CARBONATE USP

DMF 42421981

LEK PHARMACEUTICALS DDLITHIUM CARBONATE ACTIVE SUBSTANCE

DMF 156772001

SUN PHARMACEUTICAL INDUSTRIES LTDLITHIUM CARBONATE USP

DMF 208242007

EUTICALS SPALITHIUM CARBONATE PHARMA GRADE

DMF 231752009

ALIVUS LIFE SCIENCES LTDLITHIUM CARBONATE USP

DMF 336292019

HONOUR LAB LTDLITHIUM CARBONATE

DMF 392432023

UNIQUE CHEMICALS (A DIV OF J B CHEMICALS AND PHARMACEUTICALS LTD)LITHIUM CARBONATE USP

DMF 405102025

EMNAR PHARMA PRIVATE LTDLITHIUM CARBONATE

DMF 407822024

JIANGSU NHWA PHARMACEUTICAL CO LTDLITHIUM CARBONATE USP

DMF 430932025

LYNE LABORATORIES INCInactiveLITHIUM CARBONATE TABLETS

DMF 11901968

METALLGESELLSCHAFT AGInactiveLITHIUM CARBONATE

DMF 36271979

ANI PHARMACEUTICALS INCInactiveLITHIUM CARBONATE PILOT PROCESS

DMF 37781980

LEK PHARMACEUTICAL AND CHEMICAL CO DDInactiveLITHIUM CARBONATE

DMF 42931981

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

Approval Letters

8 letters from Drugs@FDA

Date	Submission	Document
Jun 3, 2004	SUPPL -73	View Letter (PDF)
Mar 16, 2004	SUPPL -74	View Letter (PDF)
May 8, 2002	SUPPL -69	View Letter (PDF)
May 8, 2002	SUPPL -72	View Letter (PDF)
May 8, 2002	SUPPL -65	View Letter (PDF)
May 8, 2002	SUPPL -59	View Letter (PDF)
May 8, 2002	SUPPL -68	View Letter (PDF)
May 8, 2002	SUPPL -67	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — 300MG

0 patents0 exclusivities▴

CAPSULE;ORAL | Approved: Approved Prior to Jan 1, 1982

No patent or exclusivity listings for this strength.