Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 079067
Company: ALEMBIC PHARMS LTD

Products on ANDA 079067

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

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 079067

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
03/13/2009	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
07/08/2024	SUPPL-23	Labeling-Package Insert		Label is not available on this site.
06/28/2024	SUPPL-22	Labeling-Package Insert		Label is not available on this site.
06/28/2024	SUPPL-18	Labeling-Container/Carton Labels, Labeling-Package Insert		Label is not available on this site.
08/18/2021	SUPPL-17	Labeling-Package Insert		Label is not available on this site.
07/24/2019	SUPPL-11	Labeling-Package Insert		Label is not available on this site.
07/24/2019	SUPPL-10	Labeling-Package Insert		Label is not available on this site.
09/11/2017	SUPPL-2	Labeling-Package Insert		Label is not available on this site.

Therapeutic Equivalents for ANDA 079067

METRONIDAZOLE

TABLET;ORAL; 250MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
METRONIDAZOLE	METRONIDAZOLE	250MG	TABLET;ORAL	Prescription	No	AB	208681	ALEMBIC
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	070772	INNOGENIX
METRONIDAZOLE	METRONIDAZOLE	250MG	TABLET;ORAL	Prescription	No	AB	208162	NOVITIUM PHARMA
METRONIDAZOLE	METRONIDAZOLE	250MG	TABLET;ORAL	Prescription	No	AB	205245	SOMERSET THERAPS LLC
METRONIDAZOLE	METRONIDAZOLE	250MG	TABLET;ORAL	Prescription	No	AB	070027	TEVA PHARMS USA
METRONIDAZOLE	METRONIDAZOLE	250MG	TABLET;ORAL	Prescription	No	AB	203458	UNICHEM
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
METRONIDAZOLE	METRONIDAZOLE	500MG	TABLET;ORAL	Prescription	No	AB	208681	ALEMBIC
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	070772	INNOGENIX
METRONIDAZOLE	METRONIDAZOLE	500MG	TABLET;ORAL	Prescription	No	AB	208162	NOVITIUM PHARMA
METRONIDAZOLE	METRONIDAZOLE	500MG	TABLET;ORAL	Prescription	No	AB	070033	PLIVA
METRONIDAZOLE	METRONIDAZOLE	500MG	TABLET;ORAL	Prescription	No	AB	205245	SOMERSET THERAPS LLC
METRONIDAZOLE	METRONIDAZOLE	500MG	TABLET;ORAL	Prescription	No	AB	203458	UNICHEM
METRONIDAZOLE	METRONIDAZOLE	500MG	TABLET;ORAL	Prescription	No	AB	070044	WATSON LABS INC