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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 091027
Company: SUN PHARM INDS INC

Products on ANDA 091027

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

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 091027

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
06/24/2010	ORIG-1	Approval				Label is not available on this site.

Therapeutic Equivalents for ANDA 091027

LITHIUM CARBONATE

TABLET;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;ORAL	Prescription	Yes	AB	018558	HIKMA
LITHIUM CARBONATE	LITHIUM CARBONATE	300MG	TABLET;ORAL	Prescription	No	AB	091027	SUN PHARM INDS INC

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