Drugs@FDA: FDA Approved Drug Products
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 | AB | 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-Package Insert, Labeling-Container/Carton Labels |
Label is not available on this site. |
TRIAMCINOLONE ACETONIDE
INJECTABLE;INJECTION; 40MG/ML
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| KENALOG-40 | TRIAMCINOLONE ACETONIDE | 40MG/ML | INJECTABLE;INJECTION | Prescription | Yes | AB | 014901 | APOTHECON |
| TRIAMCINOLONE ACETONIDE | TRIAMCINOLONE ACETONIDE | 40MG/ML | INJECTABLE;INJECTION | Prescription | No | AB | 207550 | AMNEAL |
| TRIAMCINOLONE ACETONIDE | TRIAMCINOLONE ACETONIDE | 40MG/ML | INJECTABLE;INJECTION | Prescription | No | AB | 209852 | TEVA PHARMS USA |
Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players.
Language Assistance Available: Español | 繁體中文 | Tiếng Việt | 한국어 | Tagalog | Русский | العربية | Kreyòl Ayisyen | Français | Polski | Português | Italiano | Deutsch | 日本語 | فارسی | English