Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 018740
Company: FOSUN PHARMA
Company: FOSUN PHARMA
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| METRONIDAZOLE | METRONIDAZOLE | 250MG | TABLET;ORAL | Discontinued | None | No | No |
| METRONIDAZOLE | METRONIDAZOLE | 500MG | 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 |
|---|---|---|---|---|---|---|---|
| 10/22/1982 | ORIG-1 | Approval |
Label is not available on this site. |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 12/15/2021 | SUPPL-41 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/018740s041lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/018740Orig1s041ltr.pdf | |
| 03/05/2021 | SUPPL-40 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/018740s040lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/018740Orig1s040ltr.pdf | |
| 04/27/2020 | SUPPL-39 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/018620s021,018740s039lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/018620Orig1s021, 018740Orig1s039ltr.pdf | |
| 05/09/2001 | SUPPL-36 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 07/21/1998 | SUPPL-35 | Labeling |
Please see www.fda.gov/STIC for labeling requirements on susceptibility test interpretive criteria for systemic antibacterial and antifungal drugs.
Label is not available on this site. |
||
| 08/11/1997 | SUPPL-34 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 05/05/1997 | SUPPL-33 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 11/21/1995 | SUPPL-32 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 03/13/1995 | SUPPL-31 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 08/19/1993 | SUPPL-30 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 08/19/1993 | SUPPL-29 | Labeling |
Label is not available on this site. |
||
| 05/10/1993 | SUPPL-28 | Labeling |
Label is not available on this site. |
||
| 02/22/1991 | SUPPL-27 | Labeling |
Label is not available on this site. |
||
| 05/17/1989 | SUPPL-26 | Labeling |
Label is not available on this site. |
||
| 01/28/1988 | SUPPL-24 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 01/28/1988 | SUPPL-23 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 01/28/1988 | SUPPL-22 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 01/28/1988 | SUPPL-20 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 01/28/1988 | SUPPL-19 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 01/28/1988 | SUPPL-18 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 05/09/1986 | SUPPL-15 | Manufacturing (CMC) |
Label is not available on this site. |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 12/15/2021 | SUPPL-41 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/018740s041lbl.pdf | |
| 03/05/2021 | SUPPL-40 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/018740s040lbl.pdf | |
| 04/27/2020 | SUPPL-39 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/018620s021,018740s039lbl.pdf |