Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 018620
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
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
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.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
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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