Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 075117
Company: CONCORDIA PHARMS INC

Products on ANDA 75117

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
ORAPRED	PREDNISOLONE SODIUM PHOSPHATE	EQ 15MG BASE/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**	SOLUTION;ORAL	Discontinued	None	No	No

Labels for ANDA 075117

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
12/14/2000	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/anda/2000/75-117_Orapred_prntlbl.pdf