Drugs@FDA: FDA-Approved Drugs
Company: WATSON LABS
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 |
---|---|---|---|---|---|---|---|
09/17/1982 | 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-44 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/018764s044lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/018764Orig1s044ltr.pdf | |
03/05/2021 | SUPPL-43 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/018764s043lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/018764Orig1s043ltr.pdf | |
10/17/2018 | SUPPL-42 | Labeling-Package Insert, Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/018764s042lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/018764Orig1s042ltr.pdf | |
01/24/2005 | SUPPL-31 | 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. |
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10/01/2001 | SUPPL-29 | Manufacturing (CMC) |
Label is not available on this site. |
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04/25/2001 | SUPPL-28 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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06/08/1998 | SUPPL-25 | Manufacturing (CMC) |
Label is not available on this site. |
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08/08/1997 | SUPPL-24 | Labeling |
Label is not available on this site. |
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08/22/1991 | SUPPL-21 | Labeling |
Label is not available on this site. |
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01/28/1991 | SUPPL-20 | Manufacturing (CMC) |
Label is not available on this site. |
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08/07/1991 | SUPPL-19 | Manufacturing (CMC) |
Label is not available on this site. |
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07/22/1988 | SUPPL-18 | Labeling |
Label is not available on this site. |
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06/05/1985 | SUPPL-7 | Manufacturing (CMC) |
Label is not available on this site. |
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06/05/1985 | SUPPL-6 | 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-44 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/018764s044lbl.pdf | |
03/05/2021 | SUPPL-43 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/018764s043lbl.pdf | |
10/17/2018 | SUPPL-42 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/018764s042lbl.pdf | |
10/17/2018 | SUPPL-42 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/018764s042lbl.pdf |