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Last Updated: December 18, 2025

Details for New Drug Application (NDA): 202288

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NDA 202288 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 202288

Tradename:	LITHIUM CARBONATE
Applicant:	Pharmobedient
Ingredient:	lithium carbonate
Patents:	0

Pharmacology for NDA: 202288

Medical Subject Heading (MeSH) Categories for 202288

Antidepressive Agents
Antimanic Agents
Enzyme Inhibitors

Suppliers and Packaging for NDA: 202288

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
LITHIUM CARBONATE	lithium carbonate	TABLET, EXTENDED RELEASE;ORAL	202288	ANDA	A-S Medication Solutions	50090-6052	50090-6052-0	60 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (50090-6052-0)

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET, EXTENDED RELEASE;ORAL			Strength	300MG
Approval Date:	Jun 29, 2012	TE:		RLD:	No

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