Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 080442
Company: BAUSCH
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
NUTRACORT HYDROCORTISONE 0.5% CREAM;TOPICAL Discontinued None No No
NUTRACORT HYDROCORTISONE 1% 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
04/04/1972 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
04/25/1994 SUPPL-47 Labeling

Label is not available on this site.

02/01/1991 SUPPL-46 Labeling

Label is not available on this site.

11/15/1985 SUPPL-44 Manufacturing (CMC)

Label is not available on this site.

12/23/1985 SUPPL-42 Manufacturing (CMC)

Label is not available on this site.

12/23/1985 SUPPL-41 Manufacturing (CMC)

Label is not available on this site.

03/26/1985 SUPPL-40 Manufacturing (CMC)

Label is not available on this site.

03/26/1985 SUPPL-38 Manufacturing (CMC)

Label is not available on this site.

07/18/1984 SUPPL-35 Manufacturing (CMC)

Label is not available on this site.

07/18/1984 SUPPL-34 Manufacturing (CMC)

Label is not available on this site.

12/04/1984 SUPPL-33 Manufacturing (CMC)

Label is not available on this site.

12/04/1984 SUPPL-31 Manufacturing (CMC)

Label is not available on this site.

12/04/1984 SUPPL-30 Manufacturing (CMC)

Label is not available on this site.

10/22/1982 SUPPL-28 Manufacturing (CMC)

Label is not available on this site.

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