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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 091544
Company: GLENMARK PHARMS INC

Products on ANDA 091544

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 091544

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
12/27/2010	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
08/25/2023	SUPPL-12	Labeling-Package Insert, Labeling-Patient Package Insert		Label is not available on this site.
09/09/2020	SUPPL-9	Labeling-Package Insert		Label is not available on this site.
09/09/2020	SUPPL-8	Labeling-Container/Carton Labels, Labeling-Package Insert		Label is not available on this site.
09/09/2020	SUPPL-7	Labeling-Package Insert		Label is not available on this site.
09/09/2020	SUPPL-6	Labeling-Package Insert, Labeling-Patient Package Insert		Label is not available on this site.
09/09/2020	SUPPL-4	Labeling-Package Insert		Label is not available on this site.
03/06/2012	SUPPL-2	Labeling-Package Insert		Label is not available on this site.

Therapeutic Equivalents for ANDA 091544

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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