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Last Updated: April 26, 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-two 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

Antidepressive Agents
Antimanic Agents
Enzyme Inhibitors

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:	RX	Dosage:	TABLET, EXTENDED RELEASE;ORAL			Strength	300MG
Approval Date:	Approved Prior to Jan 1, 1982	TE:	AB	RLD:	Yes

Expired US Patents for NDA 018027

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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	⤷ Try a Trial	⤷ Try a Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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