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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 085282
Company: MERICON
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
HYDROCORTISONE HYDROCORTISONE 0.5% LOTION;TOPICAL Discontinued None No No
HYDROCORTISONE HYDROCORTISONE 1% LOTION;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
06/05/1978 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
11/02/1989 SUPPL-14 Labeling

Label is not available on this site.

02/26/1987 SUPPL-12 Manufacturing (CMC)

Label is not available on this site.

02/26/1987 SUPPL-11 Manufacturing (CMC)

Label is not available on this site.

02/26/1987 SUPPL-10 Manufacturing (CMC)

Label is not available on this site.

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