Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 085825
Company: WATSON LABS
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
TRIAMCINOLONE ACETONIDE TRIAMCINOLONE ACETONIDE 40MG/ML INJECTABLE;INJECTION 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
11/05/1981 ORIG-1 Approval Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/085825_original_approval_pkg.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
02/19/1999 SUPPL-24 Manufacturing (CMC)-Microbiology-Processing

Label is not available on this site.

02/02/1999 SUPPL-23 Manufacturing (CMC)-Microbiology-Processing

Label is not available on this site.

05/28/1998 SUPPL-21 Manufacturing (CMC)

Label is not available on this site.

05/11/1990 SUPPL-19 Manufacturing (CMC)

Label is not available on this site.

05/11/1990 SUPPL-18 Manufacturing (CMC)

Label is not available on this site.

01/03/1989 SUPPL-17 Manufacturing (CMC)

Label is not available on this site.

10/04/1988 SUPPL-15 Labeling

Label is not available on this site.

12/01/1989 SUPPL-14 Manufacturing (CMC)

Label is not available on this site.

03/02/1988 SUPPL-13 Labeling

Label is not available on this site.

07/17/1986 SUPPL-10 Manufacturing (CMC)

Label is not available on this site.

02/04/1985 SUPPL-9 Manufacturing (CMC)

Label is not available on this site.

02/14/1983 SUPPL-5 Manufacturing (CMC)

Label is not available on this site.

12/27/1982 SUPPL-4 Manufacturing (CMC)

Label is not available on this site.

12/27/1982 SUPPL-3 Manufacturing (CMC)

Label is not available on this site.

03/19/1982 SUPPL-1 Manufacturing (CMC)

Label is not available on this site.

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