Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 080339
Company: FOSUN PHARMA

Products on ANDA 080339

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
PREDNISOLONE	PREDNISOLONE	5MG	TABLET;ORAL	Discontinued	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 080339

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
09/06/1972	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
06/05/2024	SUPPL-50	Labeling-Package Insert		Label is not available on this site.
04/04/1994	SUPPL-49	Labeling		Label is not available on this site.
01/24/1994	SUPPL-48	Manufacturing (CMC)		Label is not available on this site.
05/10/1990	SUPPL-47	Labeling		Label is not available on this site.
11/02/1989	SUPPL-46	Labeling		Label is not available on this site.
07/12/1989	SUPPL-45	Labeling		Label is not available on this site.
04/07/1988	SUPPL-44	Manufacturing (CMC)		Label is not available on this site.
04/07/1988	SUPPL-43	Manufacturing (CMC)		Label is not available on this site.
08/09/1985	SUPPL-42	Manufacturing (CMC)		Label is not available on this site.
08/09/1985	SUPPL-41	Manufacturing (CMC)		Label is not available on this site.
08/09/1985	SUPPL-40	Manufacturing (CMC)		Label is not available on this site.
11/05/1982	SUPPL-36	Manufacturing (CMC)		Label is not available on this site.
11/05/1982	SUPPL-35	Manufacturing (CMC)		Label is not available on this site.
10/13/1982	SUPPL-34	Manufacturing (CMC)		Label is not available on this site.
09/07/1982	SUPPL-33	Manufacturing (CMC)		Label is not available on this site.
09/07/1982	SUPPL-32	Manufacturing (CMC)		Label is not available on this site.