`
` SHARE (HTTPS://WWW.FACEBOOK.COM/SHARER/SHARER.PHP?U=HTTPS://WWW.ACCESSDATA.FDA.GOV/SCRIPTS/CDER/DAF/INDEX.CFM?EVENT=BASICSEARCH.PROCESS)
`
` TWEET (HTTPS://TWITTER.COM/INTENT/TWEET/?TEXT=DRUGS@FDA: FDA-APPROVED DRUGS&URL=HTTPS://WWW.ACCESSDATA.FDA.GOV/SCRIPTS/CDER/DAF/INDEX.CFM?
`EVENT=BASICSEARCH.PROCESS)
`
` LINKEDIN (HTTPS://WWW.LINKEDIN.COM/SHAREARTICLE?MINI=TRUE&URL=HTTPS://WWW.ACCESSDATA.FDA.GOV/SCRIPTS/CDER/DAF/INDEX.CFM?
`EVENT=BASICSEARCH.PROCESS&TITLE=DRUGS@FDA: FDA-APPROVED DRUGS&SOURCE=FDA)
`
` PIN IT (HTTPS://WWW.PINTEREST.COM/PIN/CREATE/BUTTON/?URL=HTTPS://WWW.ACCESSDATA.FDA.GOV/SCRIPTS/CDER/DAF/INDEX.CFM?
`EVENT=BASICSEARCH.PROCESS&DESCRIPTION=DRUGS@FDA: FDA-APPROVED DRUGS)
`
` EMAIL (MAILTO:?SUBJECT=DRUGS@FDA: FDA-APPROVED DRUGS&BODY=HTTPS://WWW.ACCESSDATA.FDA.GOV/SCRIPTS/CDER/DAF/INDEX.CFM?EVENT=BASICSEARCH.PROCESS)
`
`
`Home (index.cfm) | Previous Page
`
`New Drug Application (NDA): 020114
`Company: MYLAN SPECIALITY LP
`
` EMAIL (MAILTO:?SUBJECT=DRUGS@FDA: FDA APPROVED DRUG PRODUCTS&BODY=HTTP://WWW.ACCESSDATA.FDA.GOV/SCRIPTS/CDER/DAF/INDEX.CFM?
`EVENT=OVERVIEW.PROCESS%26VARAPPLNO=020114)
`
`Products on NDA 020114
`
`CSV
`
`Excel
`
`
`
`
`CIPLA LTD. EXHIBIT 2003 PAGE 1
`
`CIPLA LTD. EXHIBIT 2003 PAGE 1
`
`
`
`
`DrugDrug
`
`NameName
`
`ASTELIN
`
`
`
`Active IngredientsActive Ingredients
`
`
`
`StrengthStrength
`
`
`DosageDosage
`
`Form/RouteForm/Route
`
`
`MarketingMarketing
`
`StatusStatus
`
`
`TETE
`
`CodeCode
`
`AZELASTINE
`HYDROCHLORIDE
`
`EQ 0.125MG
`BASE/SPRAY
`
`SPRAY,
`METERED;NASAL
`
`Prescription
`
`AB
`
`
`
`RLDRLD
`
`Yes
`
`
`
`RSRS
`
`Yes
`
`Showing 1 to 1 of 1 entries
`
`Approval Date(s) and History, Letters, Labels, Reviews for NDA 020114
`
`
`
`Original Approvals or Tentative Approvals
`
`CSV
`
`Excel
`
`
`Action
`Date
`
`Submission
`
`Action
`Type
`
`Submission
`Classification
`
`11/01/1996
`
`ORIG-1
`
`Approval
`
`Type 1 - New
`Molecular Entity
`
`Review
`Priority;
`Orphan
`Status
`
`Letters, Reviews, Labels, Patient Package Insert
`
`STANDARD
`
`Review (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/nda/pre9
`
`Showing 1 to 1 of 1 entries
`
`Supplements
`
`CSV
`
`Excel
`
`
`CIPLA LTD. EXHIBIT 2003 PAGE 2
`
`CIPLA LTD. EXHIBIT 2003 PAGE 2
`
`
`
`Action
`Action
`Date
`Date
`
`Submission
`Submission
`
`09/06/2018
`
`SUPPL-28
`
`10/23/2014
`
`SUPPL-26
`
`03/13/2014
`
`SUPPL-25
`
`Supplement
`Supplement
`Categories
`Categories
`or Approval
`or Approval
`Type
`Type
`
`Letters, Reviews, Labels, Patient Package Insert
`Letters, Reviews, Labels, Patient Package Insert
`
`Note
`Note
`
`Labeling-
`Package Insert
`
`Label (PDF)
`(https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/020114s028lbl.pdf)
`
`Label (PDF)
`(https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020114s026lbl.pdf)
`Letter (PDF)
`(https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/020114Orig1s026ltr.pdf)
`
`Labeling-
`Package Insert
`
`Manufacturing
`(CMC)
`
`01/20/2012
`
`SUPPL-23
`
`Labeling-
`Package Insert
`
`Label (PDF)
`(https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020114s023lbl.pdf)
`Letter (PDF)
`(https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020114s023ltr.pdf)
`
`08/10/2007
`
`SUPPL-17
`
`Labeling
`
`Letter (PDF)
`(https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/020114s017ltr.pdf)
`
`02/17/2006
`
`SUPPL-14
`
`Efficacy-New
`Dosing Regimen
`
`Label is
`not
`available
`on this
`site.
`
`Label is
`not
`available
`on this
`site.
`
`Label is
`not
`available
`on this
`site.
`
`CIPLA LTD. EXHIBIT 2003 PAGE 3
`
`CIPLA LTD. EXHIBIT 2003 PAGE 3
`
`
`
`Action
`Date
`
`Submission
`
`06/27/2001
`
`SUPPL-7
`
`Supplement
`Categories
`or Approval
`Type
`
`Manufacturing
`(CMC)-Control
`
`10/13/2000
`
`SUPPL-3
`
`Manufacturing
`(CMC)
`
`Letters, Reviews, Labels, Patient Package Insert
`
`09/15/2000
`
`SUPPL-6
`
`Efficacy-New
`Patient
`Population
`
`Letter (PDF)
`(https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/20114S06ltr.pdf)
`Review
`(https://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/20114S006_Astelin.cfm)
`
`05/30/2000
`
`SUPPL-5
`
`Efficacy-New
`Indication
`
`Letter (PDF)
`(https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/20114S5LTR.PDF)
`
`02/16/1999
`
`SUPPL-2
`
`Labeling
`
`Note
`
`Label is
`not
`available
`on this
`site.
`
`Label is
`not
`available
`on this
`site.
`
`Label is
`not
`available
`on this
`site.
`
`Label is
`not
`available
`on this
`site.
`
`Label is
`not
`available
`on this
`site.
`
`CIPLA LTD. EXHIBIT 2003 PAGE 4
`
`CIPLA LTD. EXHIBIT 2003 PAGE 4
`
`
`
`Letters, Reviews, Labels, Patient Package Insert
`
`Action
`Date
`
`Submission
`
`Supplement
`Categories
`or Approval
`Type
`
`09/29/1997
`
`SUPPL-1
`
`Labeling
`
`Showing 1 to 12 of 12 entries
`
`Labels for NDA 020114
`
`Therapeutic Equivalents for NDA 020114
`
`Note
`
`Label is
`not
`available
`on this
`site.
`
`
`
`
`
`CIPLA LTD. EXHIBIT 2003 PAGE 5
`
`CIPLA LTD. EXHIBIT 2003 PAGE 5
`
`