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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 018930
Company: CHARTWELL MOLECULES

Products on NDA 018930

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
METRONIDAZOLE	METRONIDAZOLE	500MG	TABLET;ORAL	Discontinued	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 018930

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
12/15/2021	SUPPL-15	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-14	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-13	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-12	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-11	Labeling		Label is not available on this site.
06/16/1988	SUPPL-10	Labeling		Label is not available on this site.
06/03/1986	SUPPL-7	Manufacturing (CMC)		Label is not available on this site.
06/03/1986	SUPPL-6	Manufacturing (CMC)		Label is not available on this site.
04/08/1985	SUPPL-5	Manufacturing (CMC)		Label is not available on this site.
06/06/1985	SUPPL-4	Manufacturing (CMC)		Label is not available on this site.

Labels for NDA 018930

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
12/15/2021	SUPPL-15	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/018930s015,018845s016lbl.pdf
03/05/2021	SUPPL-14	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/018930s014,018845s015lbl.pdf
04/27/2020	SUPPL-13	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/018845s014,018930s013lbl.pdf

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