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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 018764
Company: WATSON LABS

Products on NDA 018764

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 018764

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
12/15/2021	SUPPL-44	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/018764s044lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/018764Orig1s044ltr.pdf
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.

Labels for NDA 018764

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
12/15/2021	SUPPL-44	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/018764s044lbl.pdf
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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