Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 079065
Company: ALEMBIC

Products on ANDA 079065

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
METRONIDAZOLE	METRONIDAZOLE	375MG	CAPSULE;ORAL	Prescription	AB	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 079065

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
06/23/2009	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
02/14/2025	SUPPL-22	Labeling-Package Insert		Label is not available on this site.
01/11/2024	SUPPL-17	Labeling-Container/Carton Labels, Labeling-Package Insert		Label is not available on this site.
01/11/2024	SUPPL-16	Labeling-Package Insert		Label is not available on this site.
11/04/2019	SUPPL-10	Labeling-Package Insert		Label is not available on this site.
11/04/2019	SUPPL-8	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 079065

METRONIDAZOLE

CAPSULE;ORAL; 375MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
FLAGYL	METRONIDAZOLE	375MG	CAPSULE;ORAL	Prescription	Yes	AB	020334	PFIZER
METRONIDAZOLE	METRONIDAZOLE	375MG	CAPSULE;ORAL	Prescription	No	AB	079065	ALEMBIC
METRONIDAZOLE	METRONIDAZOLE	375MG	CAPSULE;ORAL	Prescription	No	AB	076522	CHARTWELL RX