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Last Updated: December 15, 2025

Details for New Drug Application (NDA): 090702

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NDA 090702 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 090702

Tradename:	LITHIUM CARBONATE
Applicant:	Hetero Labs Ltd Iii
Ingredient:	lithium carbonate
Patents:	0

Pharmacology for NDA: 090702

Medical Subject Heading (MeSH) Categories for 090702

Antidepressive Agents
Antimanic Agents
Enzyme Inhibitors

Suppliers and Packaging for NDA: 090702

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
LITHIUM CARBONATE	lithium carbonate	CAPSULE;ORAL	090702	ANDA	Camber Pharmaceuticals, Inc.	31722-544	31722-544-01	100 CAPSULE in 1 BOTTLE (31722-544-01)
LITHIUM CARBONATE	lithium carbonate	CAPSULE;ORAL	090702	ANDA	Camber Pharmaceuticals, Inc.	31722-544	31722-544-05	500 CAPSULE in 1 BOTTLE (31722-544-05)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	CAPSULE;ORAL			Strength	150MG
Approval Date:	Sep 25, 2009	TE:	AB	RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	CAPSULE;ORAL			Strength	300MG
Approval Date:	Sep 25, 2009	TE:	AB	RLD:	No

Profile for product number 003

Active Rx/OTC/Discontinued:	RX	Dosage:	CAPSULE;ORAL			Strength	600MG
Approval Date:	Sep 25, 2009	TE:	AB	RLD:	No

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