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Last Updated: December 11, 2025

Details for New Drug Application (NDA): 079159

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NDA 079159 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 079159

Tradename:	LITHIUM CARBONATE
Applicant:	Alembic Ltd
Ingredient:	lithium carbonate
Patents:	0

Pharmacology for NDA: 079159

Medical Subject Heading (MeSH) Categories for 079159

Antidepressive Agents
Antimanic Agents
Enzyme Inhibitors

Suppliers and Packaging for NDA: 079159

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
LITHIUM CARBONATE	lithium carbonate	CAPSULE;ORAL	079159	ANDA	Alembic Pharmaceuticals Limited	46708-303	46708-303-30	30 CAPSULE in 1 BOTTLE (46708-303-30)
LITHIUM CARBONATE	lithium carbonate	CAPSULE;ORAL	079159	ANDA	Alembic Pharmaceuticals Limited	46708-303	46708-303-31	100 CAPSULE in 1 BOTTLE (46708-303-31)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	CAPSULE;ORAL			Strength	150MG
Approval Date:	Jan 12, 2009	TE:	AB	RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	CAPSULE;ORAL			Strength	300MG
Approval Date:	Jan 12, 2009	TE:	AB	RLD:	No

Profile for product number 003

Active Rx/OTC/Discontinued:	RX	Dosage:	CAPSULE;ORAL			Strength	600MG
Approval Date:	Jan 12, 2009	TE:	AB	RLD:	No

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