Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 018740
Company: FOSUN PHARMA
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
10/22/1982 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
03/05/2021 SUPPL-40 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/018740s040lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/018740Orig1s040ltr.pdf
04/27/2020 SUPPL-39 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
05/09/2001 SUPPL-36 Manufacturing (CMC)-Control

Label is not available on this site.

07/21/1998 SUPPL-35 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.

08/11/1997 SUPPL-34 Manufacturing (CMC)

Label is not available on this site.

05/05/1997 SUPPL-33 Manufacturing (CMC)

Label is not available on this site.

11/21/1995 SUPPL-32 Manufacturing (CMC)

Label is not available on this site.

03/13/1995 SUPPL-31 Manufacturing (CMC)

Label is not available on this site.

08/19/1993 SUPPL-30 Manufacturing (CMC)

Label is not available on this site.

08/19/1993 SUPPL-29 Labeling

Label is not available on this site.

05/10/1993 SUPPL-28 Labeling

Label is not available on this site.

02/22/1991 SUPPL-27 Labeling

Label is not available on this site.

05/17/1989 SUPPL-26 Labeling

Label is not available on this site.

01/28/1988 SUPPL-24 Manufacturing (CMC)

Label is not available on this site.

01/28/1988 SUPPL-23 Manufacturing (CMC)

Label is not available on this site.

01/28/1988 SUPPL-22 Manufacturing (CMC)

Label is not available on this site.

01/28/1988 SUPPL-20 Manufacturing (CMC)

Label is not available on this site.

01/28/1988 SUPPL-19 Manufacturing (CMC)

Label is not available on this site.

01/28/1988 SUPPL-18 Manufacturing (CMC)

Label is not available on this site.

05/09/1986 SUPPL-15 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-40 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/018740s040lbl.pdf
04/27/2020 SUPPL-39 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/018620s021,018740s039lbl.pdf

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