Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 012623
Company: PFIZER
Company: PFIZER
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| FLAGYL | METRONIDAZOLE | 250MG | TABLET;ORAL | Discontinued | None | Yes | No |
| FLAGYL | METRONIDAZOLE | 500MG | TABLET;ORAL | Discontinued | None | Yes | 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 |
|---|---|---|---|---|---|---|---|
| 07/18/1963 | ORIG-1 | Approval | Type 1 - New Molecular Entity | PRIORITY |
Label is not available on this site. |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 10/06/2023 | SUPPL-70 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/012623s070lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/012623Orig1s070ltr.pdf | |
| 12/15/2021 | SUPPL-69 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/012623s069lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/012623Orig1s069ltr.pdf | |
| 03/05/2021 | SUPPL-68 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/012623s068lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/012623Orig1s068ltr.pdf | |
| 04/03/2018 | SUPPL-67 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/020868s012_20334s010_012623s067lb.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/012623Orig1s067, 020334Orig1s010, 020868Orig1s012ltr.pdf | |
| 07/13/2015 | SUPPL-66 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
Please see www.fda.gov/STIC for labeling requirements on susceptibility test interpretive criteria for systemic antibacterial and antifungal drugs. | https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/012623s066lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/012623Orig1s066ltr.pdf |
| 08/16/2013 | SUPPL-65 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/012623s065lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/012623Orig1s065ltr.pdf | |
| 08/19/2010 | SUPPL-61 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/012623s061lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/012623s061,020334s004,020868s008ltr.pdf | |
| 03/17/2004 | SUPPL-59 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/12623slr059_flagyl_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/12623slr059ltr.pdf | |
| 04/23/2003 | SUPPL-58 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/12623slr058_flagyl_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/12623slr058ltr.pdf | |
| 02/16/1994 | SUPPL-56 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 06/23/1992 | SUPPL-54 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 05/07/1996 | SUPPL-53 | Labeling |
Label is not available on this site. |
||
| 07/30/1990 | SUPPL-52 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 05/07/1996 | SUPPL-51 | Labeling |
Label is not available on this site. |
||
| 04/13/1989 | SUPPL-50 | Labeling |
Label is not available on this site. |
||
| 05/07/1996 | SUPPL-49 | Labeling |
Label is not available on this site. |
||
| 05/07/1996 | SUPPL-48 | Labeling |
Label is not available on this site. |
||
| 02/03/1989 | SUPPL-47 | Labeling |
Label is not available on this site. |
||
| 06/18/1987 | SUPPL-46 | Manufacturing (CMC)-Expiration Date |
Label is not available on this site. |
||
| 12/28/1987 | SUPPL-45 | Labeling |
Label is not available on this site. |
||
| 07/22/1986 | SUPPL-44 | Labeling |
Label is not available on this site. |
||
| 02/10/1988 | SUPPL-41 | Efficacy-New Patient Population |
Label is not available on this site. |
||
| 11/03/1987 | SUPPL-40 | Labeling |
Label is not available on this site. |
||
| 08/21/1987 | SUPPL-38 | Labeling |
Label is not available on this site. |
||
| 03/30/1984 | SUPPL-37 | Labeling |
Label is not available on this site. |
||
| 06/02/1983 | SUPPL-36 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 10/18/1983 | SUPPL-35 | Labeling |
Label is not available on this site. |
||
| 10/18/1983 | SUPPL-34 | Labeling |
Label is not available on this site. |
||
| 05/05/1982 | SUPPL-33 | Manufacturing (CMC)-Formulation |
Label is not available on this site. |
||
| 08/13/1981 | SUPPL-32 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 02/04/1982 | SUPPL-31 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 08/04/1981 | SUPPL-30 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 12/12/1980 | SUPPL-29 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 01/09/1980 | SUPPL-28 | Manufacturing (CMC)-Formulation |
Label is not available on this site. |
||
| 12/08/1980 | SUPPL-27 | Labeling |
Label is not available on this site. |
||
| 02/27/1980 | SUPPL-26 | Manufacturing (CMC)-Formulation |
Label is not available on this site. |
||
| 01/02/1980 | SUPPL-25 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 07/26/1979 | SUPPL-24 | Labeling |
Label is not available on this site. |
||
| 03/02/1979 | SUPPL-23 | Labeling |
Label is not available on this site. |
||
| 04/19/1979 | SUPPL-22 | Manufacturing (CMC)-Formulation |
Label is not available on this site. |
||
| 08/22/1977 | SUPPL-19 | Labeling |
Label is not available on this site. |
||
| 10/05/1976 | SUPPL-18 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 11/05/1975 | SUPPL-15 | Labeling |
Label is not available on this site. |
||
| 05/14/1974 | SUPPL-13 | Labeling |
Label is not available on this site. |
||
| 05/14/1974 | SUPPL-12 |
Label is not available on this site. |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 10/06/2023 | SUPPL-70 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/012623s070lbl.pdf | |
| 12/15/2021 | SUPPL-69 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/012623s069lbl.pdf | |
| 03/05/2021 | SUPPL-68 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/012623s068lbl.pdf | |
| 04/03/2018 | SUPPL-67 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/020868s012_20334s010_012623s067lb.pdf | |
| 07/13/2015 | SUPPL-66 | Labeling-Package Insert | Label (PDF) | Please see www.fda.gov/STIC for labeling requirements on susceptibility test interpretive criteria for systemic antibacterial and antifungal drugs. | https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/012623s066lbl.pdf |
| 08/16/2013 | SUPPL-65 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/012623s065lbl.pdf | |
| 08/19/2010 | SUPPL-61 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/012623s061lbl.pdf | |
| 03/17/2004 | SUPPL-59 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/12623slr059_flagyl_lbl.pdf | |
| 04/23/2003 | SUPPL-58 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/12623slr058_flagyl_lbl.pdf |