Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 200222
Company: TEVA PHARMS
Company: TEVA PHARMS
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
LINEZOLID | LINEZOLID | 600MG/300ML (2MG/ML) | SOLUTION;INTRAVENOUS | 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 |
---|---|---|---|---|---|---|---|
06/27/2012 | ORIG-1 | Approval | Not Applicable |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/200222s000ltr.pdf |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
06/26/2019 | SUPPL-4 | Labeling-Package Insert |
Label is not available on this site. |
||
01/05/2016 | SUPPL-3 | Labeling-Package Insert |
Label is not available on this site. |
||
01/05/2016 | SUPPL-1 | Labeling-Package Insert |
Label is not available on this site. |