Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 040620
Company: TEVA PHARMS USA
Company: TEVA PHARMS USA
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| METHYLPREDNISOLONE ACETATE | METHYLPREDNISOLONE ACETATE | 40MG/ML | INJECTABLE;INJECTION | Discontinued | None | No | No |
| METHYLPREDNISOLONE ACETATE | METHYLPREDNISOLONE ACETATE | 80MG/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 |
|---|---|---|---|---|---|---|---|
| 10/27/2006 | ORIG-1 | Approval |
Review (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/anda/2006/040620Orig1s000BioeqR.pdf |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 08/24/2022 | SUPPL-31 | Labeling-Package Insert |
Label is not available on this site. |
||
| 08/09/2020 | SUPPL-30 | Labeling-Container/Carton Labels, Labeling-Package Insert |
Label is not available on this site. |
||
| 08/09/2020 | SUPPL-26 | Labeling-Package Insert |
Label is not available on this site. |
||
| 08/09/2020 | SUPPL-24 | Labeling-Package Insert |
Label is not available on this site. |
||
| 08/09/2020 | SUPPL-22 | Labeling-Package Insert |
Label is not available on this site. |
||
| 11/30/2010 | SUPPL-3 | Labeling-Package Insert |
Label is not available on this site. |