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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 020868
Company: PFIZER

Products on NDA 020868

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
FLAGYL ER	METRONIDAZOLE	750MG	TABLET, EXTENDED RELEASE;ORAL	Discontinued	None	Yes	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 020868

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
11/26/1997	ORIG-1	Approval	Type 3 - New Dosage Form	STANDARD	Review (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/nda/97/020868a.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
07/08/2024	SUPPL-17	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/020868s017lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/020868Orig1s017ltr.pdf
10/06/2023	SUPPL-15	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/020868s015lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/020868Orig1s015ltr.pdf
12/15/2021	SUPPL-14	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/020868s014lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/020868Orig1s014ltr.pdf
03/05/2021	SUPPL-13	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/020868s013lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/020868Orig1s013ltr.pdf
04/03/2018	SUPPL-12	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-11	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020868s011lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/020868Orig1s011ltr.pdf
04/14/2015	SUPPL-10	Manufacturing (CMC)		Label is not available on this site.
08/16/2013	SUPPL-9	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020868s009lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/020868Orig1s009ltr.pdf
08/19/2010	SUPPL-8	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020868s008lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/012623s061,020334s004,020868s008ltr.pdf
03/17/2004	SUPPL-6	Labeling	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20868slr006_flagyl_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20868slr006ltr.pdf
04/23/2003	SUPPL-5	Labeling	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/020868s005lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20868slr005ltr.pdf
11/04/1998	SUPPL-4	Manufacturing (CMC)-Packaging		Label is not available on this site.
10/08/1998	SUPPL-3	Labeling		Label is not available on this site.
07/24/1998	SUPPL-2	Manufacturing (CMC)		Label is not available on this site.
02/20/1998	SUPPL-1	Manufacturing (CMC)-Packaging		Label is not available on this site.

Labels for NDA 020868

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
07/08/2024	SUPPL-17	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/020868s017lbl.pdf
10/06/2023	SUPPL-15	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/020868s015lbl.pdf
12/15/2021	SUPPL-14	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/020868s014lbl.pdf
03/05/2021	SUPPL-13	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/020868s013lbl.pdf
04/03/2018	SUPPL-12	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/020868s012_20334s010_012623s067lb.pdf
07/13/2015	SUPPL-11	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020868s011lbl.pdf
08/16/2013	SUPPL-9	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020868s009lbl.pdf
08/19/2010	SUPPL-8	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020868s008lbl.pdf
03/17/2004	SUPPL-6	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20868slr006_flagyl_lbl.pdf
04/23/2003	SUPPL-5	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/020868s005lbl.pdf

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