Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 207550
Company: AMNEAL
Company: AMNEAL
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| TRIAMCINOLONE ACETONIDE | TRIAMCINOLONE ACETONIDE | 40MG/ML | INJECTABLE;INJECTION | Prescription | BX | 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 |
|---|---|---|---|---|---|---|---|
| 12/11/2017 | ORIG-1 | Approval | STANDARD |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/207550Orig1s000ltr.pdf |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 10/03/2019 | SUPPL-3 | Labeling-Container/Carton Labels, Labeling-Package Insert |
Label is not available on this site. |
TRIAMCINOLONE ACETONIDE
There are no Therapeutic Equivalents.
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