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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 078297
Company: AUROBINDO PHARMA

Products on ANDA 078297

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	Yes

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 078297

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				Label is not available on this site.

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
12/03/2019	SUPPL-20	Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.
12/03/2019	SUPPL-18	Labeling-Package Insert		Label is not available on this site.
12/03/2019	SUPPL-17	Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.
12/03/2019	SUPPL-16	Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.
08/25/2015	SUPPL-13	Labeling-Package Insert		Label is not available on this site.
08/25/2015	SUPPL-12	Labeling-Package Insert		Label is not available on this site.
02/05/2013	SUPPL-10	Labeling-Package Insert		Label is not available on this site.
09/21/2011	SUPPL-8	Labeling-Package Insert, Labeling-Patient Package Insert		Label is not available on this site.
07/14/2008	SUPPL-2	Labeling		Label is not available on this site.
04/04/2008	SUPPL-1	Manufacturing (CMC)-Control		Label is not available on this site.

Therapeutic Equivalents for ANDA 078297

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	077714	BRECKENRIDGE PHARM
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	076390	DR REDDYS LABS INC
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

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