Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 010060
Company: CASPER PHARMA LLC

Products on NDA 010060

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
FLORINEF	FLUDROCORTISONE ACETATE	0.1MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**	TABLET;ORAL	Discontinued	None	Yes	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 010060

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
08/18/1955	ORIG-1	Approval	Type 3 - New Dosage Form	STANDARD		Label is not available on this site.

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
06/29/2004	SUPPL-17	Labeling	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/10060slr017ltr.pdf
08/20/1999	SUPPL-16	Manufacturing (CMC)		Label is not available on this site.
03/24/1995	SUPPL-15	Labeling		Label is not available on this site.
10/11/1994	SUPPL-14	Manufacturing (CMC)		Label is not available on this site.
03/31/1993	SUPPL-13	Labeling		Label is not available on this site.
05/09/1988	SUPPL-12	Labeling		Label is not available on this site.
11/18/1982	SUPPL-10	Labeling		Label is not available on this site.
01/22/1979	SUPPL-9	Manufacturing (CMC)-Packaging		Label is not available on this site.