Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 205743
Company: PAR PHARM INC

Products on ANDA 205743

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
CITRIC ACID; MAGNESIUM OXIDE; SODIUM PICOSULFATE	CITRIC ACID; MAGNESIUM OXIDE; SODIUM PICOSULFATE	12GM/PACKET;3.5GM/PACKET;10MG/PACKET	FOR SOLUTION;ORAL	None (Tentative Approval)	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 205743

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
11/21/2016	ORIG-1	Tentative Approval		STANDARD		Label is not available on this site.