Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 085825
Company: WATSON LABS
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. |
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| 05/28/1998 | SUPPL-21 | Manufacturing (CMC) |
Label is not available on this site. |
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| 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. |
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| 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. |
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| 12/01/1989 | SUPPL-14 | Manufacturing (CMC) |
Label is not available on this site. |
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| 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. |
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| 02/04/1985 | SUPPL-9 | Manufacturing (CMC) |
Label is not available on this site. |
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| 02/14/1983 | SUPPL-5 | Manufacturing (CMC) |
Label is not available on this site. |
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| 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. |
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| 03/19/1982 | SUPPL-1 | Manufacturing (CMC) |
Label is not available on this site. |