Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 202288
Company: MYLAN PHARMS INC

Products on ANDA 202288

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 202288

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
06/29/2012	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
07/13/2020	SUPPL-6	Labeling-Package Insert		Label is not available on this site.
02/14/2020	SUPPL-5	Labeling-Package Insert		Label is not available on this site.
02/14/2020	SUPPL-4	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.

Therapeutic Equivalents for ANDA 202288

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