An official website of the United States government Here's how you know

The .gov means it's official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you're on a federal government site.

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

New Drug Application (NDA): 021479
Company: BAUSCH

Products on NDA 021479

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
ZELAPAR	SELEGILINE HYDROCHLORIDE	1.25MG	TABLET, ORALLY DISINTEGRATING;ORAL	Prescription	None	Yes	Yes

Approval Date(s) and History, Letters, Labels, Reviews for NDA 021479

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
06/14/2006	ORIG-1	Approval	Type 3 - New Dosage Form	STANDARD	Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021479lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021479s000LTR.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2006/021479_zelapar_toc.cfm

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
06/16/2021	SUPPL-10	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/021479s010lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/021479Orig1s010ltr.pdf
08/19/2019	SUPPL-8	Labeling-Container/Carton Labels	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/021479Orig1s008ltr.pdf
10/09/2015	SUPPL-7	Manufacturing (CMC)		Label is not available on this site.
07/31/2014	SUPPL-5	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021479s005lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021479Orig1s005ltr.pdf
12/31/2008	SUPPL-4	Labeling	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021479s003s004lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021479s003,021479s004ltr.pdf
12/31/2008	SUPPL-3	Labeling	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021479s003s004lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021479s003,021479s004ltr.pdf

Labels for NDA 021479

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
06/16/2021	SUPPL-10	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/021479s010lbl.pdf
07/31/2014	SUPPL-5	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021479s005lbl.pdf
12/31/2008	SUPPL-4	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021479s003s004lbl.pdf
12/31/2008	SUPPL-3	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021479s003s004lbl.pdf
06/14/2006	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021479lbl.pdf

Top