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Last Updated: December 18, 2025

Details for New Drug Application (NDA): 091027

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NDA 091027 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 091027

Tradename:	LITHIUM CARBONATE
Applicant:	Sun Pharm Inds Inc
Ingredient:	lithium carbonate
Patents:	0

Pharmacology for NDA: 091027

Medical Subject Heading (MeSH) Categories for 091027

Antidepressive Agents
Antimanic Agents
Enzyme Inhibitors

Suppliers and Packaging for NDA: 091027

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
LITHIUM CARBONATE	lithium carbonate	TABLET;ORAL	091027	ANDA	Sun Pharmaceutical Industries, Inc.	62756-430	62756-430-08	100 TABLET in 1 BOTTLE (62756-430-08)
LITHIUM CARBONATE	lithium carbonate	TABLET;ORAL	091027	ANDA	Sun Pharmaceutical Industries, Inc.	62756-430	62756-430-18	1000 TABLET in 1 BOTTLE (62756-430-18)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	300MG
Approval Date:	Jun 24, 2010	TE:	AB	RLD:	No

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