Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 070027
Company: TEVA PHARMS USA
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
METRONIDAZOLE METRONIDAZOLE 250MG 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
12/06/1984 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
08/14/2019 SUPPL-44 Labeling-Package Insert

Label is not available on this site.

08/14/2019 SUPPL-43 Labeling-Package Insert

Label is not available on this site.

09/05/2017 SUPPL-42 Labeling-Package Insert

Label is not available on this site.

07/21/2014 SUPPL-41 Labeling-Package Insert

Label is not available on this site.

12/24/2014 SUPPL-37 Labeling-Package Insert

Label is not available on this site.

09/28/2010 SUPPL-35 Labeling-Package Insert

Label is not available on this site.

10/25/2007 SUPPL-29 Labeling

Label is not available on this site.

05/29/2001 SUPPL-19 Manufacturing (CMC)-Facility

Label is not available on this site.

06/27/2001 SUPPL-18 Manufacturing (CMC)-Control

Label is not available on this site.

07/07/2000 SUPPL-17 Manufacturing (CMC)-Facility

Label is not available on this site.

05/21/1997 SUPPL-16 Labeling

Label is not available on this site.

05/11/1994 SUPPL-15 Manufacturing (CMC)

Label is not available on this site.

06/22/1993 SUPPL-14 Labeling

Label is not available on this site.

09/01/1992 SUPPL-13 Labeling

Label is not available on this site.

10/12/1990 SUPPL-12 Manufacturing (CMC)

Label is not available on this site.

10/24/1989 SUPPL-11 Labeling

Label is not available on this site.

04/22/1986 SUPPL-8 Manufacturing (CMC)

Label is not available on this site.

05/21/1985 SUPPL-6 Manufacturing (CMC)

Label is not available on this site.

05/21/1985 SUPPL-4 Manufacturing (CMC)

Label is not available on this site.

05/21/1985 SUPPL-3 Manufacturing (CMC)

Label is not available on this site.

05/21/1985 SUPPL-2 Manufacturing (CMC)

Label is not available on this site.

05/21/1985 SUPPL-1 Manufacturing (CMC)

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

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