Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 086008
Company: BIOGLAN
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
ALPHADERM HYDROCORTISONE; UREA 1%;10% CREAM;TOPICAL Discontinued None No 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
01/20/1978 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
10/19/1987 SUPPL-14 Manufacturing (CMC)

Label is not available on this site.

10/19/1987 SUPPL-13 Manufacturing (CMC)

Label is not available on this site.

06/01/1983 SUPPL-10 Manufacturing (CMC)

Label is not available on this site.

05/18/1982 SUPPL-8 Manufacturing (CMC)

Label is not available on this site.

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