Drugs@FDA: FDA Approved Drug Products

Home | Previous Page

New Drug Application (NDA): 021127
Company: MYLAN SPECIALITY LP
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
OPTIVAR AZELASTINE HYDROCHLORIDE 0.05% **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** SOLUTION/DROPS;OPHTHALMIC Discontinued None Yes No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
05/22/2000 ORIG-1 Approval Type 3 - New Dosage Form STANDARD Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/label/2000/21127lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/21127ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/21127_Optivar.cfm
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
07/03/2008 SUPPL-13 Labeling-Container/Carton Labels Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021127s013lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021127s013ltr.pdf
04/30/2004 SUPPL-8 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21127slr007,008_optivar_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21127slr007,008ltr.pdf
04/30/2004 SUPPL-7 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21127slr007,008_optivar_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21127slr007,008ltr.pdf
09/03/2004 SUPPL-3 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21127s003ltr.pdf
04/04/2001 SUPPL-2 Manufacturing (CMC)-Expiration Date

Label is not available on this site.

05/04/2001 SUPPL-1 Manufacturing (CMC)-Control

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
07/03/2008 SUPPL-13 Labeling-Container/Carton Labels Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021127s013lbl.pdf
04/30/2004 SUPPL-8 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21127slr007,008_optivar_lbl.pdf
04/30/2004 SUPPL-7 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21127slr007,008_optivar_lbl.pdf
05/22/2000 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2000/21127lbl.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