Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 074871
Company: APOTEX

Products on ANDA 074871

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
SELEGILINE HYDROCHLORIDE	SELEGILINE HYDROCHLORIDE	5MG	TABLET;ORAL	Prescription	AB	No	Yes

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 074871

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
06/06/1997	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
12/01/2009	SUPPL-9	Labeling-Package Insert		Label is not available on this site.
08/18/1999	SUPPL-4	Manufacturing (CMC)		Label is not available on this site.
10/20/1998	SUPPL-3	Labeling		Label is not available on this site.
06/16/1999	SUPPL-2	Labeling		Label is not available on this site.
06/16/1999	SUPPL-1	Manufacturing (CMC)		Label is not available on this site.

Therapeutic Equivalents for ANDA 074871

SELEGILINE HYDROCHLORIDE

TABLET;ORAL; 5MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
SELEGILINE HYDROCHLORIDE	SELEGILINE HYDROCHLORIDE	5MG	TABLET;ORAL	Prescription	No	AB	074871	APOTEX
SELEGILINE HYDROCHLORIDE	SELEGILINE HYDROCHLORIDE	5MG	TABLET;ORAL	Prescription	No	AB	074672	I3 PHARMS