Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 070772
Company: INNOGENIX
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
METRONIDAZOLE METRONIDAZOLE 250MG TABLET;ORAL Prescription AB No No
METRONIDAZOLE METRONIDAZOLE 500MG TABLET;ORAL Prescription AB No No
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
07/16/1986 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
02/19/2016 SUPPL-38 Labeling

Label is not available on this site.

03/28/2012 SUPPL-33 Labeling-Package Insert

Label is not available on this site.

08/15/2005 SUPPL-27 Labeling

Label is not available on this site.

03/28/2005 SUPPL-26 Labeling

Label is not available on this site.

12/13/2002 SUPPL-19 Manufacturing (CMC)-Control

Label is not available on this site.

07/29/2002 SUPPL-18 Manufacturing (CMC)-Control

Label is not available on this site.

09/17/2001 SUPPL-17 Labeling

Label is not available on this site.

09/17/2001 SUPPL-16 Manufacturing (CMC)-Packaging

Label is not available on this site.

05/02/2001 SUPPL-15 Manufacturing (CMC)-Control

Label is not available on this site.

05/16/2000 SUPPL-14 Manufacturing (CMC)-Facility

Label is not available on this site.

05/16/2000 SUPPL-13 Manufacturing (CMC)-Facility

Label is not available on this site.

12/05/1997 SUPPL-12 Manufacturing (CMC)

Label is not available on this site.

09/26/1997 SUPPL-11 Manufacturing (CMC)

Label is not available on this site.

09/26/1997 SUPPL-10 Manufacturing (CMC)

Label is not available on this site.

05/21/1997 SUPPL-9 Labeling

Label is not available on this site.

02/24/1997 SUPPL-8 Manufacturing (CMC)

Label is not available on this site.

05/22/1996 SUPPL-7 Labeling

Label is not available on this site.

11/15/1995 SUPPL-6 Labeling

Label is not available on this site.

06/22/1995 SUPPL-5 Manufacturing (CMC)

Label is not available on this site.

01/12/1994 SUPPL-4 Manufacturing (CMC)

Label is not available on this site.

06/03/1991 SUPPL-3 Labeling

Label is not available on this site.

03/28/1991 SUPPL-2 Manufacturing (CMC)

Label is not available on this site.

11/03/1989 SUPPL-1 Labeling

Label is not available on this site.

METRONIDAZOLE

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 206560 CADILA
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 070040 STRIDES PHARMA
METRONIDAZOLE METRONIDAZOLE 250MG TABLET;ORAL Prescription No AB 208162 STRIDES PHARMA
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

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 206560 CADILA
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 070039 STRIDES PHARMA
METRONIDAZOLE METRONIDAZOLE 500MG TABLET;ORAL Prescription No AB 208162 STRIDES PHARMA
METRONIDAZOLE METRONIDAZOLE 500MG TABLET;ORAL Prescription No AB 203458 UNICHEM LABS LTD
METRONIDAZOLE METRONIDAZOLE 500MG TABLET;ORAL Prescription No AB 070044 WATSON LABS INC

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