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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 020334
Company: PFIZER

Products on NDA 020334

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
FLAGYL	METRONIDAZOLE	375MG	CAPSULE;ORAL	Prescription	AB	Yes	Yes

Approval Date(s) and History, Letters, Labels, Reviews for NDA 020334

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
05/03/1995	ORIG-1	Approval	Type 5 - New Formulation or New Manufacturer	STANDARD		Label is not available on this site.

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
10/06/2023	SUPPL-13	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/020334s013lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/020334Orig1s013ltr.pdf
12/15/2021	SUPPL-12	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/020334s012lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/020334Orig1s012ltr.pdf
03/05/2021	SUPPL-11	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/020334s011lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/020334Orig1s011ltr.pdf
04/03/2018	SUPPL-10	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/020868s012_20334s010_012623s067lb.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/012623Orig1s067,020334Orig1s010,020868Orig1s012ltr.pdf
07/13/2015	SUPPL-9	Labeling-Package Insert	Label (PDF) Letter (PDF)	Please see www.fda.gov/STIC for labeling requirements on susceptibility test interpretive criteria for systemic antibacterial and antifungal drugs.	https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020334s009lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/020334Orig1s009ltr.pdf
08/16/2013	SUPPL-8	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020334s008lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/020334Orig1s008ltr.pdf
08/19/2010	SUPPL-4	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020334s004lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/012623s061,020334s004,020868s008ltr.pdf
03/17/2004	SUPPL-3	Labeling	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20334slr003_flagyl_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20334slr003ltr.pdf
04/23/2003	SUPPL-1	Labeling	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/020334s001lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20334slr001ltr.pdf

Labels for NDA 020334

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
10/06/2023	SUPPL-13	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/020334s013lbl.pdf
12/15/2021	SUPPL-12	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/020334s012lbl.pdf
03/05/2021	SUPPL-11	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/020334s011lbl.pdf
04/03/2018	SUPPL-10	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/020868s012_20334s010_012623s067lb.pdf
07/13/2015	SUPPL-9	Labeling-Package Insert	Label (PDF)	Please see www.fda.gov/STIC for labeling requirements on susceptibility test interpretive criteria for systemic antibacterial and antifungal drugs.	https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020334s009lbl.pdf
08/16/2013	SUPPL-8	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020334s008lbl.pdf
08/19/2010	SUPPL-4	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020334s004lbl.pdf
03/17/2004	SUPPL-3	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20334slr003_flagyl_lbl.pdf
04/23/2003	SUPPL-1	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/020334s001lbl.pdf

Therapeutic Equivalents for NDA 020334

FLAGYL

CAPSULE;ORAL; 375MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
FLAGYL	METRONIDAZOLE	375MG	CAPSULE;ORAL	Prescription	Yes	AB	020334	PFIZER
METRONIDAZOLE	METRONIDAZOLE	375MG	CAPSULE;ORAL	Prescription	No	AB	079065	ALEMBIC
METRONIDAZOLE	METRONIDAZOLE	375MG	CAPSULE;ORAL	Prescription	No	AB	076522	CHARTWELL RX

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