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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 011601
Company: NORVIUM BIOSCIENCE

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
TRIAMCINOLONE ACETONIDE TRIAMCINOLONE ACETONIDE 0.025% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** CREAM;TOPICAL Discontinued None Yes No
TRIAMCINOLONE ACETONIDE TRIAMCINOLONE ACETONIDE 0.1% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** CREAM;TOPICAL Discontinued None Yes No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
10/23/1958 ORIG-1 Approval Type 3 - New Dosage Form STANDARD

Label is not available on this site.
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
04/22/2016 SUPPL-43 Manufacturing (CMC)

Label is not available on this site.
03/15/1996 SUPPL-42 Manufacturing (CMC)-Control

Label is not available on this site.
06/04/1987 SUPPL-40 Manufacturing (CMC)-Control

Label is not available on this site.
04/15/1986 SUPPL-39 Manufacturing (CMC)-Control

Label is not available on this site.
08/08/1984 SUPPL-38 Manufacturing (CMC)

Label is not available on this site.
03/18/1982 SUPPL-37 Manufacturing (CMC)-Expiration Date

Label is not available on this site.
12/13/1982 SUPPL-36 Labeling Label (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/pre96/011601s036lbl.pdf
03/24/1980 SUPPL-35 Labeling

Label is not available on this site.
04/17/1979 SUPPL-34 Labeling

Label is not available on this site.
02/05/1979 SUPPL-33 Manufacturing (CMC)-Control

Label is not available on this site.
11/13/1978 SUPPL-32 Manufacturing (CMC)-Formulation

Label is not available on this site.
07/05/1978 SUPPL-31 Labeling

Label is not available on this site.
10/11/1977 SUPPL-29 Manufacturing (CMC)

Label is not available on this site.
10/11/1977 SUPPL-28 Manufacturing (CMC)-Control

Label is not available on this site.
05/23/1977 SUPPL-27 Labeling

Label is not available on this site.
05/27/1977 SUPPL-26 Manufacturing (CMC)-Control

Label is not available on this site.
01/31/1977 SUPPL-25 Manufacturing (CMC)

Label is not available on this site.
07/08/1976 SUPPL-24 Manufacturing (CMC)-Formulation

Label is not available on this site.
04/28/1976 SUPPL-23 Manufacturing (CMC)-Formulation

Label is not available on this site.
03/06/1975 SUPPL-20 Manufacturing (CMC)-Control

Label is not available on this site.
03/06/1975 SUPPL-19 Manufacturing (CMC)-Control

Label is not available on this site.
09/13/1974 SUPPL-18 Labeling

Label is not available on this site.
07/18/1974 SUPPL-17

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert		 Note Url
12/13/1982 SUPPL-36 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/pre96/011601s036lbl.pdf
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