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Last Updated: December 11, 2025

Details for New Drug Application (NDA): 017812


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NDA 017812 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 017812
Tradename:LITHIUM CARBONATE
Applicant:Hikma
Ingredient:lithium carbonate
Patents:0
Pharmacology for NDA: 017812
Medical Subject Heading (MeSH) Categories for 017812
Antidepressive Agents
Antimanic Agents
Enzyme Inhibitors
Suppliers and Packaging for NDA: 017812
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
LITHIUM CARBONATE lithium carbonate CAPSULE;ORAL 017812 NDA Hikma Pharmaceuticals USA Inc. 0054-2526 0054-2526-25 100 CAPSULE, GELATIN COATED in 1 BOTTLE (0054-2526-25)
LITHIUM CARBONATE lithium carbonate CAPSULE;ORAL 017812 NDA Hikma Pharmaceuticals USA Inc. 0054-2527 0054-2527-25 100 CAPSULE, GELATIN COATED in 1 BOTTLE (0054-2527-25)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength300MG
Approval Date:Approved Prior to Jan 1, 1982TE:ABRLD:Yes

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength150MG
Approval Date:Jan 28, 1987TE:ABRLD:Yes

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength600MG
Approval Date:Jan 28, 1987TE:ABRLD:Yes

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Preferred Citation:

Friedman, Yali. "DrugPatentWatch" DrugPatentWatch, thinkBiotech, 2025, www.DrugPatentWatch.com.
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