Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 018764
Company: WATSON LABS
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
09/17/1982 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-43 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/018764s043lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/018764Orig1s043ltr.pdf
10/17/2018 SUPPL-42 Labeling-Package Insert, Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/018764s042lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/018764Orig1s042ltr.pdf
01/24/2005 SUPPL-31 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.

10/01/2001 SUPPL-29 Manufacturing (CMC)

Label is not available on this site.

04/25/2001 SUPPL-28 Manufacturing (CMC)-Control

Label is not available on this site.

06/08/1998 SUPPL-25 Manufacturing (CMC)

Label is not available on this site.

08/08/1997 SUPPL-24 Labeling

Label is not available on this site.

08/22/1991 SUPPL-21 Labeling

Label is not available on this site.

01/28/1991 SUPPL-20 Manufacturing (CMC)

Label is not available on this site.

08/07/1991 SUPPL-19 Manufacturing (CMC)

Label is not available on this site.

07/22/1988 SUPPL-18 Labeling

Label is not available on this site.

06/05/1985 SUPPL-7 Manufacturing (CMC)

Label is not available on this site.

06/05/1985 SUPPL-6 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-43 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/018764s043lbl.pdf
10/17/2018 SUPPL-42 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/018764s042lbl.pdf
10/17/2018 SUPPL-42 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/018764s042lbl.pdf

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