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Last Updated: December 11, 2025

Details for New Drug Application (NDA): 091544

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NDA 091544 describes LITHIUM CARBONATE, which is a drug marketed by Able, Alembic Ltd, Apotex Inc, Glenmark Pharms Ltd, Hetero Labs Ltd Iii, Hikma, Pharmobedient, Usl Pharma, Watson Labs, Alembic, Glenmark Pharms Inc, Heritage Pharma, Hikma Intl Pharms, Unique, Pfizer, and Sun Pharm Inds Inc, and is included in twenty-nine NDAs. It is available from twenty suppliers. Additional details are available on the LITHIUM CARBONATE profile page.

The generic ingredient in LITHIUM CARBONATE is lithium carbonate. There are fifteen drug master file entries for this compound. Twenty-one suppliers are listed for this compound. Additional details are available on the lithium carbonate profile page.

Summary for 091544

Tradename:	LITHIUM CARBONATE
Applicant:	Glenmark Pharms Inc
Ingredient:	lithium carbonate
Patents:	0

Pharmacology for NDA: 091544

Medical Subject Heading (MeSH) Categories for 091544

Antidepressive Agents
Antimanic Agents
Enzyme Inhibitors

Suppliers and Packaging for NDA: 091544

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
LITHIUM CARBONATE	lithium carbonate	TABLET, EXTENDED RELEASE;ORAL	091544	ANDA	A-S Medication Solutions	50090-1470	50090-1470-0	60 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (50090-1470-0)
LITHIUM CARBONATE	lithium carbonate	TABLET, EXTENDED RELEASE;ORAL	091544	ANDA	Coupler LLC	67046-1575	67046-1575-3	30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK (67046-1575-3)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET, EXTENDED RELEASE;ORAL			Strength	300MG
Approval Date:	Dec 27, 2010	TE:	AB	RLD:	No

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