Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 018845
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
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.

06/03/1986 SUPPL-8 Manufacturing (CMC)

Label is not available on this site.

06/03/1986 SUPPL-7 Manufacturing (CMC)

Label is not available on this site.

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
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

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