Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 205532
Company: HERITAGE PHARMA

Products on ANDA 205532

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 205532

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
09/29/2016	ORIG-1	Approval		STANDARD		Label is not available on this site.

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
04/21/2025	SUPPL-14	Labeling-Package Insert		Label is not available on this site.
04/21/2025	SUPPL-9	Labeling-Container/Carton Labels, Labeling-Package Insert		Label is not available on this site.
02/14/2020	SUPPL-3	Labeling-Package Insert		Label is not available on this site.
05/06/2019	SUPPL-2	Labeling-Package Insert		Label is not available on this site.
02/14/2020	SUPPL-1	Labeling-Package Insert, Labeling-Container/Carton Labels		Label is not available on this site.

Therapeutic Equivalents for ANDA 205532

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
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	204779	UNIQUE
LITHOBID	LITHIUM CARBONATE	300MG	TABLET, EXTENDED RELEASE;ORAL	Prescription	Yes	AB	018027	ANI PHARMS