Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 040090
Company: OMNIVIUM PHARMS

Products on ANDA 040090

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
ISONIAZID	ISONIAZID	100MG	TABLET;ORAL	Prescription	AA	No	Yes
ISONIAZID	ISONIAZID	300MG	TABLET;ORAL	Prescription	AA	No	Yes

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 040090

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
06/26/1997	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
02/05/2025	SUPPL-7	Labeling-Package Insert		Label is not available on this site.
01/27/2025	SUPPL-6	Labeling-Container/Carton Labels, Labeling-Package Insert		Label is not available on this site.
01/27/2025	SUPPL-5	Labeling-Package Insert		Label is not available on this site.
08/13/2002	SUPPL-2	Manufacturing (CMC)-Facility		Label is not available on this site.
07/31/1998	SUPPL-1	Manufacturing (CMC)		Label is not available on this site.

Therapeutic Equivalents for ANDA 040090

ISONIAZID

TABLET;ORAL; 100MG
TE Code = AA

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
ISONIAZID	ISONIAZID	100MG	TABLET;ORAL	Prescription	No	AA	040090	OMNIVIUM PHARMS
ISONIAZID	ISONIAZID	100MG	TABLET;ORAL	Prescription	No	AA	202610	THEPHARMANETWORK LLC

TABLET;ORAL; 300MG
TE Code = AA

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
ISONIAZID	ISONIAZID	300MG	TABLET;ORAL	Prescription	No	AA	040090	OMNIVIUM PHARMS
ISONIAZID	ISONIAZID	300MG	TABLET;ORAL	Prescription	No	AA	202610	THEPHARMANETWORK LLC