Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 080443
Company: DOW PHARM
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
NUTRACORT HYDROCORTISONE 0.5% LOTION;TOPICAL Discontinued None No No
NUTRACORT 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
04/26/1972 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
07/15/2002 SUPPL-32 Manufacturing (CMC)

Label is not available on this site.

10/23/2001 SUPPL-31 Manufacturing (CMC)

Label is not available on this site.

07/30/1993 SUPPL-30 Labeling

Label is not available on this site.

02/11/1991 SUPPL-29 Labeling

Label is not available on this site.

07/26/1985 SUPPL-26 Manufacturing (CMC)

Label is not available on this site.

11/21/1988 SUPPL-25 Labeling

Label is not available on this site.

11/21/1988 SUPPL-24 Manufacturing (CMC)

Label is not available on this site.

11/21/1988 SUPPL-23 Manufacturing (CMC)

Label is not available on this site.

01/25/1983 SUPPL-21 Manufacturing (CMC)

Label is not available on this site.

08/17/1998 SUPPL-1 Manufacturing (CMC)

Label is not available on this site.

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