Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 010060
Company: CASPER PHARMA LLC
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FLORINEF FLUDROCORTISONE ACETATE 0.1MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** TABLET;ORAL Discontinued None Yes No
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.

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