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Last Updated: December 19, 2025

Details for New Drug Application (NDA): 204779

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NDA 204779 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 204779

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

Pharmacology for NDA: 204779

Medical Subject Heading (MeSH) Categories for 204779

Antidepressive Agents
Antimanic Agents
Enzyme Inhibitors

Suppliers and Packaging for NDA: 204779

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
LITHIUM CARBONATE	lithium carbonate	TABLET, EXTENDED RELEASE;ORAL	204779	ANDA	Rising Pharma Holdings, Inc.	64980-205	64980-205-01	100 TABLET, EXTENDED RELEASE in 1 BOTTLE (64980-205-01)
LITHIUM CARBONATE	lithium carbonate	TABLET, EXTENDED RELEASE;ORAL	204779	ANDA	Rising Pharma Holdings, Inc.	64980-205	64980-205-03	30 TABLET, EXTENDED RELEASE in 1 BOTTLE (64980-205-03)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET, EXTENDED RELEASE;ORAL			Strength	300MG
Approval Date:	Jul 27, 2015	TE:	AB	RLD:	No

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