Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 075321
Company: APOTEX

Products on ANDA 075321

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

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 075321

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
12/04/1998	ORIG-1	Approval			Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/75321ltr.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
05/31/2011	SUPPL-6	Labeling-Package Insert		Label is not available on this site.
11/30/2010	SUPPL-5	Labeling-Package Insert		Label is not available on this site.
08/06/2010	SUPPL-4	Labeling-Package Insert		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 075321

SELEGILINE HYDROCHLORIDE

CAPSULE;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	CAPSULE;ORAL	Prescription	No	AB	075321	APOTEX
SELEGILINE HYDROCHLORIDE	SELEGILINE HYDROCHLORIDE	5MG	CAPSULE;ORAL	Prescription	No	AB	075352	NOVITIUM PHARMA
SELEGILINE HYDROCHLORIDE	SELEGILINE HYDROCHLORIDE	5MG	CAPSULE;ORAL	Prescription	No	AB	206803	RISING