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Serving leading biopharmaceutical companies globally:

Citi
QuintilesIMS
McKinsey
Harvard Business School
Johnson and Johnson
Covington
UBS
Farmers Insurance
Cantor Fitzgerald
Cerilliant

Generated: December 10, 2017

DrugPatentWatch Database Preview

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. Thirty-four suppliers are listed for this compound. Additional details are available on the lithium carbonate profile page.

Summary for 018027

Tradename:1
Applicant:1
Ingredient:1
Patents:0
Therapeutic Class:Bipolar Agents
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)

Summary for product number 001

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

Expired Orange Book Patents for NDA: 018027

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Ani Pharms IncLITHOBIDlithium carbonateTABLET, EXTENDED RELEASE;ORAL018027-001Approved Prior to Jan 1, 1982► Subscribe► Subscribe
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Serving leading biopharmaceutical companies globally:

Medtronic
QuintilesIMS
Moodys
Cipla
AstraZeneca
Colorcon
UBS
Cantor Fitzgerald
US Army
US Department of Justice

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