Drugs@FDA: FDA Approved Drug Products

Home | Previous Page

New Drug Application (NDA): 019334
Company: SOMERSET
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
SELEGILINE HYDROCHLORIDE SELEGILINE HYDROCHLORIDE 5MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** TABLET;ORAL Discontinued None Yes No
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
06/05/1989 ORIG-1 Approval Type 1 - New Molecular Entity PRIORITY; Orphan

Label is not available on this site.

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
12/31/2008 SUPPL-20 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/019334s019s020lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/019334s020,019334s019ltr.pdf
12/31/2008 SUPPL-19 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/019334s019s020lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/019334s020,019334s019ltr.pdf
08/06/1997 SUPPL-17 Labeling

Label is not available on this site.

07/13/1994 SUPPL-12 Manufacturing (CMC)-Control

Label is not available on this site.

02/12/1993 SUPPL-11 Manufacturing (CMC)-Control

Label is not available on this site.

01/05/1993 SUPPL-9 Manufacturing (CMC)

Label is not available on this site.

01/05/1993 SUPPL-8 Manufacturing (CMC)-Control

Label is not available on this site.

01/05/1993 SUPPL-7 Labeling

Label is not available on this site.

01/05/1993 SUPPL-6 Manufacturing (CMC)

Label is not available on this site.

01/05/1993 SUPPL-5 Labeling

Label is not available on this site.

07/25/1990 SUPPL-3 Labeling

Label is not available on this site.

03/01/1990 SUPPL-2 Manufacturing (CMC)-Packaging

Label is not available on this site.

03/26/1990 SUPPL-1 Labeling

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
12/31/2008 SUPPL-20 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/019334s019s020lbl.pdf
12/31/2008 SUPPL-19 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/019334s019s020lbl.pdf

Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players.
Language Assistance Available: Español | 繁體中文 | Tiếng Việt | 한국어 | Tagalog | Русский | العربية | Kreyòl Ayisyen | Français | Polski | Português | Italiano | Deutsch | 日本語 | فارسی | English