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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 076832
Company: HIKMA

Products on ANDA 076832

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
LITHIUM CARBONATE	LITHIUM CARBONATE	300MG	TABLET, EXTENDED RELEASE;ORAL	Prescription	AB	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 076832

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
10/28/2004	ORIG-1	Approval			Review (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/anda/2004/076832Orig1s000.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
02/14/2020	SUPPL-13	Labeling-Package Insert		Label is not available on this site.
02/14/2020	SUPPL-12	Labeling-Package Insert		Label is not available on this site.
02/14/2020	SUPPL-11	Labeling-Package Insert		Label is not available on this site.
03/06/2012	SUPPL-9	Labeling-Package Insert		Label is not available on this site.
12/26/2007	SUPPL-5	Labeling		Label is not available on this site.
09/28/2007	SUPPL-3	Labeling		Label is not available on this site.

Therapeutic Equivalents for ANDA 076832

LITHIUM CARBONATE

TABLET, EXTENDED RELEASE;ORAL; 300MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
LITHIUM CARBONATE	LITHIUM CARBONATE	300MG	TABLET, EXTENDED RELEASE;ORAL	Prescription	No	AB	091544	GLENMARK PHARMS INC
LITHIUM CARBONATE	LITHIUM CARBONATE	300MG	TABLET, EXTENDED RELEASE;ORAL	Prescription	No	AB	205532	HERITAGE PHARMA
LITHIUM CARBONATE	LITHIUM CARBONATE	300MG	TABLET, EXTENDED RELEASE;ORAL	Prescription	No	AB	076832	HIKMA
LITHIUM CARBONATE	LITHIUM CARBONATE	300MG	TABLET, EXTENDED RELEASE;ORAL	Prescription	No	AB	202288	MYLAN PHARMS INC
LITHIUM CARBONATE	LITHIUM CARBONATE	300MG	TABLET, EXTENDED RELEASE;ORAL	Prescription	No	AB	204779	UNIQUE
LITHOBID	LITHIUM CARBONATE	300MG	TABLET, EXTENDED RELEASE;ORAL	Prescription	Yes	AB	018027	ANI PHARMS

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