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Last Updated: March 28, 2024

Details for New Drug Application (NDA): 204445


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NDA 204445 describes LITHIUM CARBONATE, which is a drug marketed by Able, Alembic Ltd, Apotex Inc, Glenmark Generics, Hetero Labs Ltd Iii, Hikma, Mylan, Usl Pharma, Watson Labs, Alembic, Glenmark Pharms Inc, Heritage Pharma, Hikma Intl Pharms, Mylan Pharms Inc, Unique, Pfizer, and Sun Pharm Inds Inc, and is included in twenty-nine NDAs. It is available from twenty-one 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-two suppliers are listed for this compound. Additional details are available on the lithium carbonate profile page.
Summary for 204445
Tradename:LITHIUM CARBONATE
Applicant:Alembic
Ingredient:lithium carbonate
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 204445
Medical Subject Heading (MeSH) Categories for 204445
Suppliers and Packaging for NDA: 204445
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
LITHIUM CARBONATE lithium carbonate TABLET, EXTENDED RELEASE;ORAL 204445 ANDA Alembic Pharmaceuticals Limited 46708-148 46708-148-08 80 TABLET, EXTENDED RELEASE in 1 CARTON (46708-148-08)
LITHIUM CARBONATE lithium carbonate TABLET, EXTENDED RELEASE;ORAL 204445 ANDA Alembic Pharmaceuticals Limited 46708-148 46708-148-30 30 TABLET, EXTENDED RELEASE in 1 BOTTLE (46708-148-30)

Profile for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:TABLET, EXTENDED RELEASE;ORALStrength300MG
Approval Date:Jun 10, 2015TE:RLD:No

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