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Last Updated: July 22, 2024

Details for New Drug Application (NDA): 018027


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NDA 018027 describes LITHOBID, which is a drug marketed by Ani Pharms 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-three suppliers are listed for this compound. Additional details are available on the lithium carbonate profile page.
Summary for 018027
Tradename:LITHOBID
Applicant:Ani Pharms
Ingredient:lithium carbonate
Patents:0
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 Proficient Rx LP 71205-238 71205-238-30 30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (71205-238-30)

Profile for product number 001

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

Expired US Patents for NDA 018027

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Ani Pharms LITHOBID lithium carbonate TABLET, EXTENDED RELEASE;ORAL 018027-001 Approved Prior to Jan 1, 1982 ⤷  Sign Up ⤷  Sign Up
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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