Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

Abbreviated New Drug Application (ANDA): 076490
Company: HIKMA INTL PHARMS

Products on ANDA 076490

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
LITHIUM CARBONATE	LITHIUM CARBONATE	450MG	TABLET, EXTENDED RELEASE;ORAL	Discontinued	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 076490

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
06/17/2003	ORIG-1	Approval				Label is not available on this site.

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
02/05/2020	SUPPL-12	Labeling-Package Insert		Label is not available on this site.
12/20/2018	SUPPL-11	Labeling-Package Insert		Label is not available on this site.
12/06/2018	SUPPL-10	Labeling-Package Insert		Label is not available on this site.
10/05/2007	SUPPL-3	Labeling		Label is not available on this site.
06/19/2007	SUPPL-2	Manufacturing (CMC)-Control		Label is not available on this site.
01/31/2007	SUPPL-1	Labeling		Label is not available on this site.