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Last Updated: June 22, 2021

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Details for New Drug Application (NDA): 018027

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NDA 018027 describes LITHOBID, which is a drug marketed by Ani Pharms Inc and is included in one NDA. It is available from two suppliers. Additional details are available on the LITHOBID profile page.

The generic ingredient in LITHOBID is lithium carbonate. There are fifteen drug master file entries for this compound. Twenty-four suppliers are listed for this compound. Additional details are available on the lithium carbonate profile page.
Summary for 018027
Applicant:Ani Pharms Inc
Ingredient:lithium carbonate
Formulation / Manufacturing:see details
Pharmacology for NDA: 018027
Medical Subject Heading (MeSH) Categories for 018027
Suppliers and Packaging for NDA: 018027
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
LITHOBID lithium carbonate TABLET, EXTENDED RELEASE;ORAL 018027 NDA ANI Pharmaceuticals, Inc. 62559-280 62559-280-01 100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (62559-280-01)
LITHOBID lithium carbonate TABLET, EXTENDED RELEASE;ORAL 018027 NDA AUTHORIZED GENERIC ANI Pharmaceuticals, Inc. 62559-340 62559-340-01 100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (62559-340-01)

Profile for product number 001

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

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