Drugs@FDA: FDA-Approved Drugs

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

Products on ANDA 075117

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PREDNISOLONE SODIUM PHOSPHATE	EQ 15MG BASE/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**	SOLUTION;ORAL	Discontinued	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 075117

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
12/14/2000	ORIG-1	Approval			Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/anda/2000/75-117_Orapred_prntlbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/75117ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/anda/2000/75-117_Orapred.cfm

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
06/16/2005	SUPPL-12	Labeling		Label is not available on this site.
11/07/2002	SUPPL-6	Manufacturing (CMC)-Control		Label is not available on this site.
05/08/2002	SUPPL-5	Manufacturing (CMC)-Control		Label is not available on this site.
08/28/2001	SUPPL-4	Manufacturing (CMC)-Control		Label is not available on this site.
08/28/2001	SUPPL-3	Manufacturing (CMC)-Facility		Label is not available on this site.
06/25/2001	SUPPL-2	Manufacturing (CMC)-Facility		Label is not available on this site.
03/28/2001	SUPPL-1	Manufacturing (CMC)		Label is not available on this site.

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