Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 084343
Company: DELCOR ASSET CORP
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
KENALOG TRIAMCINOLONE ACETONIDE 0.025% **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** LOTION;TOPICAL Discontinued None No No
KENALOG TRIAMCINOLONE ACETONIDE 0.1% **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** LOTION;TOPICAL Discontinued None No No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
07/16/1974 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
11/09/1992 SUPPL-31 Manufacturing (CMC)

Label is not available on this site.

06/28/1983 SUPPL-25 Manufacturing (CMC)

Label is not available on this site.

05/05/1983 SUPPL-24 Manufacturing (CMC)

Label is not available on this site.

12/01/1982 SUPPL-23 Manufacturing (CMC)

Label is not available on this site.

06/21/1982 SUPPL-22 Manufacturing (CMC)

Label is not available on this site.

12/21/1981 SUPPL-21 Manufacturing (CMC)

Label is not available on this site.

12/21/1981 SUPPL-18 Manufacturing (CMC)

Label is not available on this site.

12/21/1981 SUPPL-17 Manufacturing (CMC)

Label is not available on this site.

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