Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 076522
Company: CHARTWELL RX

Products on ANDA 076522

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 076522

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
01/29/2004	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
11/27/2023	SUPPL-11	Labeling-Patient Package Insert		Label is not available on this site.
10/22/2010	SUPPL-8	Labeling-Package Insert		Label is not available on this site.
06/27/2007	SUPPL-6	Labeling		Label is not available on this site.
01/21/2005	SUPPL-2	Labeling		Label is not available on this site.

Therapeutic Equivalents for ANDA 076522

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