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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 077533
Company: INVAGEN PHARMS

Products on ANDA 077533

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
TERBINAFINE HYDROCHLORIDE	TERBINAFINE HYDROCHLORIDE	EQ 250MG BASE	TABLET;ORAL	Prescription	AB	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 077533

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
07/02/2007	ORIG-1	Approval			Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/077533s000_ltr.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
09/11/2025	SUPPL-17	Labeling-Package Insert, Labeling-Medication Guide		Label is not available on this site.
09/11/2025	SUPPL-14	Labeling-Package Insert, Labeling-Medication Guide		Label is not available on this site.
01/10/2016	SUPPL-12	Labeling-Patient Package Insert, Labeling-Package Insert		Label is not available on this site.
01/10/2016	SUPPL-10	Labeling-Package Insert, Labeling-Medication Guide		Label is not available on this site.
07/12/2012	SUPPL-5	Labeling-Patient Package Insert, Labeling-Package Insert		Label is not available on this site.
09/20/2011	SUPPL-3	Labeling-Package Insert, Labeling-Container/Carton Labels, Labeling-Patient Package Insert		Label is not available on this site.

Therapeutic Equivalents for ANDA 077533

TERBINAFINE HYDROCHLORIDE

TABLET;ORAL; EQ 250MG BASE
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
TERBINAFINE HYDROCHLORIDE	TERBINAFINE HYDROCHLORIDE	EQ 250MG BASE	TABLET;ORAL	Prescription	No	AB	078297	AUROBINDO PHARMA
TERBINAFINE HYDROCHLORIDE	TERBINAFINE HYDROCHLORIDE	EQ 250MG BASE	TABLET;ORAL	Prescription	No	AB	078199	CHARTWELL
TERBINAFINE HYDROCHLORIDE	TERBINAFINE HYDROCHLORIDE	EQ 250MG BASE	TABLET;ORAL	Prescription	No	AB	077137	CIPLA
TERBINAFINE HYDROCHLORIDE	TERBINAFINE HYDROCHLORIDE	EQ 250MG BASE	TABLET;ORAL	Prescription	No	AB	077919	EMED MEDCL
TERBINAFINE HYDROCHLORIDE	TERBINAFINE HYDROCHLORIDE	EQ 250MG BASE	TABLET;ORAL	Prescription	No	AB	078157	GLENMARK PHARMS LTD
TERBINAFINE HYDROCHLORIDE	TERBINAFINE HYDROCHLORIDE	EQ 250MG BASE	TABLET;ORAL	Prescription	No	AB	077533	INVAGEN PHARMS
TERBINAFINE HYDROCHLORIDE	TERBINAFINE HYDROCHLORIDE	EQ 250MG BASE	TABLET;ORAL	Prescription	No	AB	078163	ORBION PHARMS
TERBINAFINE HYDROCHLORIDE	TERBINAFINE HYDROCHLORIDE	EQ 250MG BASE	TABLET;ORAL	Prescription	No	AB	076390	SENORES PHARMS

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