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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 083231
Company: DERM RX
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
ALA-SCALP HYDROCORTISONE 2% LOTION;TOPICAL Prescription 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
02/28/1973 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
01/22/2015 SUPPL-7 Labeling

Label is not available on this site.

05/20/1991 SUPPL-5 Labeling

Label is not available on this site.

06/07/1990 SUPPL-4 Labeling

Label is not available on this site.

03/26/1982 SUPPL-3 Manufacturing (CMC)

Label is not available on this site.

05/11/1982 SUPPL-2 Manufacturing (CMC)

Label is not available on this site.

05/11/1982 SUPPL-1 Manufacturing (CMC)

Label is not available on this site.

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