Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 202610
Company: THEPHARMANETWORK LLC

Products on ANDA 202610

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

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 202610

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
10/29/2014	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-1	Labeling-Package Insert		Label is not available on this site.

Therapeutic Equivalents for ANDA 202610

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