Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 012623
Company: GD SEARLE LLC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
FLAGYL METRONIDAZOLE 250MG TABLET;ORAL Prescription AB Yes No
FLAGYL METRONIDAZOLE 500MG TABLET;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
07/18/1963 ORIG-1 Approval Type 1 - New Molecular Entity PRIORITY

Label is not available on this site.

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
04/03/2018 SUPPL-67 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-66 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/2015/012623s066lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/012623Orig1s066ltr.pdf
08/16/2013 SUPPL-65 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/012623s065lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/012623Orig1s065ltr.pdf
08/19/2010 SUPPL-61 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/012623s061lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/012623s061,020334s004,020868s008ltr.pdf
03/17/2004 SUPPL-59 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/12623slr059_flagyl_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/12623slr059ltr.pdf
04/23/2003 SUPPL-58 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/12623slr058_flagyl_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/12623slr058ltr.pdf
02/16/1994 SUPPL-56 Manufacturing (CMC)-Packaging

Label is not available on this site.

06/23/1992 SUPPL-54 Manufacturing (CMC)-Packaging

Label is not available on this site.

05/07/1996 SUPPL-53 Labeling

Label is not available on this site.

07/30/1990 SUPPL-52 Manufacturing (CMC)-Packaging

Label is not available on this site.

05/07/1996 SUPPL-51 Labeling

Label is not available on this site.

04/13/1989 SUPPL-50 Labeling

Label is not available on this site.

05/07/1996 SUPPL-49 Labeling

Label is not available on this site.

05/07/1996 SUPPL-48 Labeling

Label is not available on this site.

02/03/1989 SUPPL-47 Labeling

Label is not available on this site.

06/18/1987 SUPPL-46 Manufacturing (CMC)-Expiration Date

Label is not available on this site.

12/28/1987 SUPPL-45 Labeling

Label is not available on this site.

07/22/1986 SUPPL-44 Labeling

Label is not available on this site.

02/10/1988 SUPPL-41 Efficacy-New Patient Population

Label is not available on this site.

11/03/1987 SUPPL-40 Labeling

Label is not available on this site.

08/21/1987 SUPPL-38 Labeling

Label is not available on this site.

03/30/1984 SUPPL-37 Labeling

Label is not available on this site.

06/02/1983 SUPPL-36 Manufacturing (CMC)-Control

Label is not available on this site.

10/18/1983 SUPPL-35 Labeling

Label is not available on this site.

10/18/1983 SUPPL-34 Labeling

Label is not available on this site.

05/05/1982 SUPPL-33 Manufacturing (CMC)-Formulation

Label is not available on this site.

08/13/1981 SUPPL-32 Manufacturing (CMC)-Packaging

Label is not available on this site.

02/04/1982 SUPPL-31 Manufacturing (CMC)

Label is not available on this site.

08/04/1981 SUPPL-30 Manufacturing (CMC)

Label is not available on this site.

12/12/1980 SUPPL-29 Manufacturing (CMC)-Packaging

Label is not available on this site.

01/09/1980 SUPPL-28 Manufacturing (CMC)-Formulation

Label is not available on this site.

12/08/1980 SUPPL-27 Labeling

Label is not available on this site.

02/27/1980 SUPPL-26 Manufacturing (CMC)-Formulation

Label is not available on this site.

01/02/1980 SUPPL-25 Manufacturing (CMC)

Label is not available on this site.

07/26/1979 SUPPL-24 Labeling

Label is not available on this site.

03/02/1979 SUPPL-23 Labeling

Label is not available on this site.

04/19/1979 SUPPL-22 Manufacturing (CMC)-Formulation

Label is not available on this site.

08/22/1977 SUPPL-19 Labeling

Label is not available on this site.

10/05/1976 SUPPL-18 Manufacturing (CMC)-Control

Label is not available on this site.

11/05/1975 SUPPL-15 Labeling

Label is not available on this site.

05/14/1974 SUPPL-13 Labeling

Label is not available on this site.

05/14/1974 SUPPL-12

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-67 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/020868s012_20334s010_012623s067lb.pdf
07/13/2015 SUPPL-66 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/2015/012623s066lbl.pdf
08/16/2013 SUPPL-65 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/012623s065lbl.pdf
08/19/2010 SUPPL-61 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/012623s061lbl.pdf
03/17/2004 SUPPL-59 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/12623slr059_flagyl_lbl.pdf
04/23/2003 SUPPL-58 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/12623slr058_flagyl_lbl.pdf

FLAGYL

TABLET;ORAL; 250MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
FLAGYL METRONIDAZOLE 250MG TABLET;ORAL Prescription Yes AB 012623 GD SEARLE LLC
METRONIDAZOLE METRONIDAZOLE 250MG TABLET;ORAL Prescription No AB 079067 ALEMBIC PHARMS LTD
METRONIDAZOLE METRONIDAZOLE 250MG TABLET;ORAL Prescription No AB 203974 AUROBINDO PHARMA LTD
METRONIDAZOLE METRONIDAZOLE 250MG TABLET;ORAL Prescription No AB 209794 CADILA PHARMS LTD
METRONIDAZOLE METRONIDAZOLE 250MG TABLET;ORAL Prescription No AB 207309 FLAMINGO PHARMS
METRONIDAZOLE METRONIDAZOLE 250MG TABLET;ORAL Prescription No AB 205245 HERITAGE PHARMS INC
METRONIDAZOLE METRONIDAZOLE 250MG TABLET;ORAL Prescription No AB 070772 INNOGENIX
METRONIDAZOLE METRONIDAZOLE 250MG TABLET;ORAL Prescription No AB 209096 LUPIN LTD
METRONIDAZOLE METRONIDAZOLE 250MG TABLET;ORAL Prescription No AB 208681 ORIT LABS LLC
METRONIDAZOLE METRONIDAZOLE 250MG TABLET;ORAL Prescription No AB 208162 STRIDES PHARMA
METRONIDAZOLE METRONIDAZOLE 250MG TABLET;ORAL Prescription No AB 070040 STRIDES VIVIMED
METRONIDAZOLE METRONIDAZOLE 250MG TABLET;ORAL Prescription No AB 070027 TEVA PHARMS USA
METRONIDAZOLE METRONIDAZOLE 250MG TABLET;ORAL Prescription No AB 203458 UNICHEM LABS LTD
METRONIDAZOLE METRONIDAZOLE 250MG TABLET;ORAL Prescription No AB 070035 WATSON LABS
METRONIDAZOLE METRONIDAZOLE 250MG TABLET;ORAL Prescription No AB 206560 ZYDUS PHARMS USA INC

TABLET;ORAL; 500MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
FLAGYL METRONIDAZOLE 500MG TABLET;ORAL Prescription Yes AB 012623 GD SEARLE LLC
METRONIDAZOLE METRONIDAZOLE 500MG TABLET;ORAL Prescription No AB 079067 ALEMBIC PHARMS LTD
METRONIDAZOLE METRONIDAZOLE 500MG TABLET;ORAL Prescription No AB 203974 AUROBINDO PHARMA LTD
METRONIDAZOLE METRONIDAZOLE 500MG TABLET;ORAL Prescription No AB 209794 CADILA PHARMS LTD
METRONIDAZOLE METRONIDAZOLE 500MG TABLET;ORAL Prescription No AB 207309 FLAMINGO PHARMS
METRONIDAZOLE METRONIDAZOLE 500MG TABLET;ORAL Prescription No AB 205245 HERITAGE PHARMS INC
METRONIDAZOLE METRONIDAZOLE 500MG TABLET;ORAL Prescription No AB 070772 INNOGENIX
METRONIDAZOLE METRONIDAZOLE 500MG TABLET;ORAL Prescription No AB 209096 LUPIN LTD
METRONIDAZOLE METRONIDAZOLE 500MG TABLET;ORAL Prescription No AB 208681 ORIT LABS LLC
METRONIDAZOLE METRONIDAZOLE 500MG TABLET;ORAL Prescription No AB 070033 PLIVA
METRONIDAZOLE METRONIDAZOLE 500MG TABLET;ORAL Prescription No AB 208162 STRIDES PHARMA
METRONIDAZOLE METRONIDAZOLE 500MG TABLET;ORAL Prescription No AB 070039 STRIDES VIVIMED
METRONIDAZOLE METRONIDAZOLE 500MG TABLET;ORAL Prescription No AB 203458 UNICHEM LABS LTD
METRONIDAZOLE METRONIDAZOLE 500MG TABLET;ORAL Prescription No AB 070044 WATSON LABS INC
METRONIDAZOLE METRONIDAZOLE 500MG TABLET;ORAL Prescription No AB 206560 ZYDUS PHARMS USA INC

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