Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 070035
Company: WATSON LABS
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
12/20/1984 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
08/13/2019 SUPPL-59 Labeling-Package Insert

Label is not available on this site.

06/30/2014 SUPPL-57 Labeling-Package Insert

Label is not available on this site.

08/02/2013 SUPPL-56 Labeling-Package Insert

Label is not available on this site.

08/30/2001 SUPPL-42 Manufacturing (CMC)-Facility

Label is not available on this site.

07/07/2000 SUPPL-39 Manufacturing (CMC)-Facility

Label is not available on this site.

03/23/2000 SUPPL-38 Manufacturing (CMC)-Manufacturing Process

Label is not available on this site.

06/08/1998 SUPPL-37 Manufacturing (CMC)

Label is not available on this site.

03/06/1997 SUPPL-36 Labeling

Label is not available on this site.

08/28/1997 SUPPL-35 Manufacturing (CMC)

Label is not available on this site.

07/08/1997 SUPPL-34 Manufacturing (CMC)

Label is not available on this site.

08/16/1996 SUPPL-33 Manufacturing (CMC)

Label is not available on this site.

02/05/1996 SUPPL-32 Manufacturing (CMC)

Label is not available on this site.

11/14/1995 SUPPL-31 Labeling

Label is not available on this site.

10/03/1995 SUPPL-30 Manufacturing (CMC)

Label is not available on this site.

10/03/1995 SUPPL-29 Manufacturing (CMC)

Label is not available on this site.

10/03/1995 SUPPL-28 Manufacturing (CMC)

Label is not available on this site.

01/26/1994 SUPPL-27 Manufacturing (CMC)

Label is not available on this site.

01/26/1994 SUPPL-26 Manufacturing (CMC)

Label is not available on this site.

01/26/1994 SUPPL-25 Manufacturing (CMC)

Label is not available on this site.

04/28/1994 SUPPL-24 Manufacturing (CMC)

Label is not available on this site.

04/28/1994 SUPPL-23 Manufacturing (CMC)

Label is not available on this site.

04/28/1994 SUPPL-22 Manufacturing (CMC)

Label is not available on this site.

04/28/1994 SUPPL-21 Manufacturing (CMC)

Label is not available on this site.

07/30/1993 SUPPL-20 Manufacturing (CMC)

Label is not available on this site.

08/31/1993 SUPPL-19 Manufacturing (CMC)

Label is not available on this site.

08/31/1993 SUPPL-18 Manufacturing (CMC)

Label is not available on this site.

05/25/1993 SUPPL-17 Manufacturing (CMC)

Label is not available on this site.

05/25/1993 SUPPL-16 Manufacturing (CMC)

Label is not available on this site.

05/25/1993 SUPPL-15 Manufacturing (CMC)

Label is not available on this site.

05/25/1993 SUPPL-14 Manufacturing (CMC)

Label is not available on this site.

05/25/1993 SUPPL-13 Manufacturing (CMC)

Label is not available on this site.

05/25/1993 SUPPL-12 Manufacturing (CMC)

Label is not available on this site.

04/01/1993 SUPPL-11 Manufacturing (CMC)

Label is not available on this site.

04/01/1993 SUPPL-10 Manufacturing (CMC)

Label is not available on this site.

04/01/1993 SUPPL-9 Manufacturing (CMC)

Label is not available on this site.

08/27/1991 SUPPL-8 Labeling

Label is not available on this site.

03/04/1986 SUPPL-3 Manufacturing (CMC)

Label is not available on this site.

03/04/1986 SUPPL-2 Manufacturing (CMC)

Label is not available on this site.

03/04/1986 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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