Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 202058
Company: HEC PHARM
Company: HEC PHARM
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| ZIDOVUDINE | ZIDOVUDINE | 300MG | TABLET;ORAL | 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 |
|---|---|---|---|---|---|---|---|
| 10/07/2011 | ORIG-1 | Approval |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/202058s000ltr.pdf |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 01/22/2020 | SUPPL-14 | Labeling-Package Insert |
Label is not available on this site. |
||
| 01/22/2020 | SUPPL-9 | Labeling-Package Insert |
Label is not available on this site. |
||
| 06/03/2013 | SUPPL-3 | Labeling-Package Insert |
Label is not available on this site. |
||
| 02/01/2013 | SUPPL-2 | Labeling-Container/Carton Labels, Labeling-Package Insert |
Label is not available on this site. |