Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 205663
Company: UNIQUE

Products on ANDA 205663

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
LITHIUM CARBONATE	LITHIUM CARBONATE	450MG	TABLET, EXTENDED RELEASE;ORAL	Prescription	AB	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 205663

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
06/05/2017	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
10/13/2022	SUPPL-9	Labeling-Package Insert		Label is not available on this site.
02/28/2020	SUPPL-5	Labeling-Package Insert		Label is not available on this site.
12/20/2018	SUPPL-2	Labeling-Package Insert		Label is not available on this site.
12/07/2018	SUPPL-1	Labeling-Package Insert		Label is not available on this site.

Therapeutic Equivalents for ANDA 205663

LITHIUM CARBONATE

TABLET, EXTENDED RELEASE;ORAL; 450MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
LITHIUM CARBONATE	LITHIUM CARBONATE	450MG	TABLET, EXTENDED RELEASE;ORAL	Prescription	No	AB	091616	GLENMARK PHARMS LTD
LITHIUM CARBONATE	LITHIUM CARBONATE	450MG	TABLET, EXTENDED RELEASE;ORAL	Prescription	No	AB	076691	HIKMA
LITHIUM CARBONATE	LITHIUM CARBONATE	450MG	TABLET, EXTENDED RELEASE;ORAL	Prescription	No	AB	202219	MYLAN PHARMS INC
LITHIUM CARBONATE	LITHIUM CARBONATE	450MG	TABLET, EXTENDED RELEASE;ORAL	Prescription	No	AB	205663	UNIQUE