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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 one supplier. 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-five suppliers are listed for this compound. Additional details are available on the lithium carbonate profile page.

Summary for NDA: 018027

Tradename:
LITHOBID
Applicant:
Ani Pharms Inc
Ingredient:
lithium carbonate
Patents:0
Therapeutic Class:Bipolar Agents
Formulation / Manufacturing:see details

Pharmacology for NDA: 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)

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 Inc
LITHOBID
lithium carbonate
TABLET, EXTENDED RELEASE;ORAL018027-001Approved Prior to Jan 1, 19824,264,573► subscribe
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