Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 020868
Company: GD SEARLE LLC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
FLAGYL ER METRONIDAZOLE 750MG TABLET, EXTENDED RELEASE;ORAL Prescription AB Yes Yes
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
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.

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

FLAGYL ER

TABLET, EXTENDED RELEASE;ORAL; 750MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
FLAGYL ER METRONIDAZOLE 750MG TABLET, EXTENDED RELEASE;ORAL Prescription Yes AB 020868 GD SEARLE LLC
METRONIDAZOLE METRONIDAZOLE 750MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB 090222 ALEMBIC PHARMS LTD

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