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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 018620
Company: FOSUN PHARMA

Products on NDA 018620

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

Approval Date(s) and History, Letters, Labels, Reviews for NDA 018620

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
03/04/1982	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-23	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/018620s023lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/018620Orig1s023ltr.pdf
03/05/2021	SUPPL-22	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/018620s022lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/018620Orig1s022ltr.pdf
04/27/2020	SUPPL-21	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/018620s021,018740s039lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/018620Orig1s021, 018740Orig1s039ltr.pdf
06/12/1995	SUPPL-20	Manufacturing (CMC)		Label is not available on this site.
11/06/1992	SUPPL-19	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.
07/17/1992	SUPPL-18	Labeling		Label is not available on this site.
01/10/1992	SUPPL-17	Labeling		Label is not available on this site.
10/17/1994	SUPPL-16	Manufacturing (CMC)		Label is not available on this site.
02/15/1991	SUPPL-15	Labeling		Label is not available on this site.
02/04/1991	SUPPL-14	Manufacturing (CMC)		Label is not available on this site.
10/27/1989	SUPPL-13	Labeling		Label is not available on this site.
11/29/1988	SUPPL-12	Labeling		Label is not available on this site.
10/02/1985	SUPPL-11	Manufacturing (CMC)		Label is not available on this site.
12/20/1985	SUPPL-10	Manufacturing (CMC)		Label is not available on this site.

Labels for NDA 018620

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
12/15/2021	SUPPL-23	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/018620s023lbl.pdf
03/05/2021	SUPPL-22	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/018620s022lbl.pdf
04/27/2020	SUPPL-21	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/018620s021,018740s039lbl.pdf

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