Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 018845
Company: CHARTWELL MOLECULES
Company: CHARTWELL MOLECULES
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
METRONIDAZOLE | METRONIDAZOLE | 250MG | 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 |
---|---|---|---|---|---|---|---|
08/18/1983 | 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 |
---|---|---|---|---|---|
07/08/2024 | SUPPL-17 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/018930s016,018845s017lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/018930Orig1s016,018845Orig1s017ltr.pdf | |
12/15/2021 | SUPPL-16 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/018930s015,018845s016lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/018930Orig1s015;018845Orig1s016ltr.pdf | |
03/05/2021 | SUPPL-15 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/018930s014,018845s015lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/018845Orig1s015; 018930Orig1s014ltr.pdf | |
04/27/2020 | SUPPL-14 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/018845s014,018930s013lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/018845Orig1s014, 018930Orig1s013ltr.pdf | |
04/16/1992 | SUPPL-13 | 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. |
||
11/03/1988 | SUPPL-12 | Labeling |
Label is not available on this site. |
||
06/16/1988 | SUPPL-11 | Labeling |
Label is not available on this site. |
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06/03/1986 | SUPPL-8 | Manufacturing (CMC) |
Label is not available on this site. |
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06/03/1986 | SUPPL-7 | Manufacturing (CMC) |
Label is not available on this site. |
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04/04/1985 | SUPPL-6 | Manufacturing (CMC) |
Label is not available on this site. |
||
05/23/1985 | SUPPL-5 | 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 |
---|---|---|---|---|---|
07/08/2024 | SUPPL-17 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/018930s016,018845s017lbl.pdf | |
12/15/2021 | SUPPL-16 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/018930s015,018845s016lbl.pdf | |
03/05/2021 | SUPPL-15 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/018930s014,018845s015lbl.pdf | |
04/27/2020 | SUPPL-14 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/018845s014,018930s013lbl.pdf |