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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 079159
Company: ALEMBIC LTD

Products on ANDA 079159

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
LITHIUM CARBONATE	LITHIUM CARBONATE	150MG	CAPSULE;ORAL	Prescription	AB	No	No
LITHIUM CARBONATE	LITHIUM CARBONATE	300MG	CAPSULE;ORAL	Prescription	AB	No	No
LITHIUM CARBONATE	LITHIUM CARBONATE	600MG	CAPSULE;ORAL	Prescription	AB	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 079159

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
01/12/2009	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
01/05/2023	SUPPL-12	Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.
09/11/2020	SUPPL-8	Labeling-Package Insert		Label is not available on this site.
09/11/2020	SUPPL-5	Labeling-Package Insert, Labeling-Medication Guide		Label is not available on this site.
09/11/2020	SUPPL-2	Labeling-Package Insert, Labeling-Container/Carton Labels, Labeling-Medication Guide		Label is not available on this site.
03/06/2012	SUPPL-1	Labeling-Package Insert, Labeling-Container/Carton Labels		Label is not available on this site.

Therapeutic Equivalents for ANDA 079159

LITHIUM CARBONATE

CAPSULE;ORAL; 150MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
LITHIUM CARBONATE	LITHIUM CARBONATE	150MG	CAPSULE;ORAL	Prescription	No	AB	079159	ALEMBIC LTD
LITHIUM CARBONATE	LITHIUM CARBONATE	150MG	CAPSULE;ORAL	Prescription	No	AB	079139	GLENMARK PHARMS LTD
LITHIUM CARBONATE	LITHIUM CARBONATE	150MG	CAPSULE;ORAL	Prescription	No	AB	090702	HETERO LABS LTD III
LITHIUM CARBONATE	LITHIUM CARBONATE	150MG	CAPSULE;ORAL	Prescription	Yes	AB	017812	HIKMA

CAPSULE;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	CAPSULE;ORAL	Prescription	No	AB	079159	ALEMBIC LTD
LITHIUM CARBONATE	LITHIUM CARBONATE	300MG	CAPSULE;ORAL	Prescription	No	AB	079139	GLENMARK PHARMS LTD
LITHIUM CARBONATE	LITHIUM CARBONATE	300MG	CAPSULE;ORAL	Prescription	No	AB	090702	HETERO LABS LTD III
LITHIUM CARBONATE	LITHIUM CARBONATE	300MG	CAPSULE;ORAL	Prescription	Yes	AB	017812	HIKMA

CAPSULE;ORAL; 600MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
LITHIUM CARBONATE	LITHIUM CARBONATE	600MG	CAPSULE;ORAL	Prescription	No	AB	079159	ALEMBIC LTD
LITHIUM CARBONATE	LITHIUM CARBONATE	600MG	CAPSULE;ORAL	Prescription	No	AB	079139	GLENMARK PHARMS LTD
LITHIUM CARBONATE	LITHIUM CARBONATE	600MG	CAPSULE;ORAL	Prescription	No	AB	090702	HETERO LABS LTD III
LITHIUM CARBONATE	LITHIUM CARBONATE	600MG	CAPSULE;ORAL	Prescription	Yes	AB	017812	HIKMA

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