`
`Drugs@FDA: FDA Approved Drug Products
`
`Drugs@FDA: FDA Approved Drug Products
`
`lf";:HARE IKTTPS:JIWWW.FACEBOOK.COM/SHARERISHARER.PHP?U=HTTPS:/IWWW.ACCESSDATA.FDA.GOV/SCRIPTS/CDERIDAF/INDEX.CFM?EVENT=BASICSEARCH.PROCESS!
`
`~ JWEET !HTTPS:/nwiTTER.COM/INTENTnwEET/?TEXT=DRUGS®FDA: FDA APPROVED DRUG
`PRODUCTS&URL=HTTPS:IIWWW.ACCESSDATA.FDA.GOV/SCRIPTS/CDERIDAF/INDEX.CFM?EVENT=BASICSEARCH.PROCESS!
`
`• EMAIL IMAILTO:?SUBJECT=DRUGS®FDA: FDA APPROVED DRUG PRODUCTS&BODY=HTTPS:IIWWW.ACCESSDATA.FDA.GOV/SCRIPTS/CDERIDAF/INDEX.CFM?
`EVENT=BASICSEARCH.PROCESS!
`
`New Drug Application (NDA): 020645
`Company: MEDICIS
`
`I !,,;EMAIL IMAILTO:?SUBJECT=DRUGS®FDA: FDA APPROVED DRUG PRODUCTS&BODY=HTTP:/IWWW.ACCESSDATA.FDA.GOV/SCRIPTS/CDERIDAF/INDEX.CFM?
`
`~ NT=OVERVIEW.PROCESS%26VARAPPLN0=020645l
`
`Products on NPA 020645
`
`csv
`
`Excel
`
`Print j
`
`Drug
`Name
`
`Active
`Ingredients
`
`v
`
`Strength
`
`Dosage Form/Route
`
`Marketing
`Status
`
`TE
`Code
`
`RLD
`
`RS
`
`AMMONUL
`
`SODIUM BENZOATE;
`SODIUM
`PHENYL.ACETATE
`
`10%;10"/o
`(5GM/50ML;SGM/50ML)
`
`Showing 1 to 1 of 1 entries
`
`SOLUTION; INTRAVENOUS
`
`Prescription
`
`AP
`
`Yes
`
`Yes
`
`Approval Date(s) and History. Letters. Labels. Reviews for NDA 020645
`
`Original Approvals or Tentative Approvals
`[Csv Excel
`
`Print I
`
`Action
`Date
`
`Submission
`
`Action
`Type
`
`Submission
`Classification
`
`02/17/2005 ORIG-1
`
`Approval
`
`Type 3- New
`Dosage Form
`
`Review
`Priority;
`Orphan
`Status
`
`PRIORITY
`
`Showing 1 to 1 of 1 entries
`
`Letters, Reviews, Labels, Patient Package Insert
`
`Label (PDF) (https:l/www.accessdata.fda.gov/drugsatfda_docs/lab
`Letter (PDF) (https:l/www.accessdata.fda.gov/drugsatfda_docs/apl
`Review (https:l/www.accessdata. fda.gov/drugsatfda_docs/nda/200
`
`https://www.accessdata.fda.gov/scripts/cder/daflindex.cfm?event=BasicSearch.process
`
`1/2
`
`Par Pharmaceutical, Inc. Ex. 1031
`Par v. Horizon, IPR of Patent No. 9,561,197
`Page 1 of 2
`
`
`
`6/29/2018
`
`Drugs@FDA: FDA Approved Drug Prcx:Jucts
`
`Supplements
`
`CSV
`
`Excel
`
`
`Action
`Date
`
`Submission
`
`01/10/2017
`
`SUPPL-10
`
`Supplement
`Categories
`or Approval
`Type
`
`Manufacturing
`(CMC)
`
`08/07/2013
`
`SUPPL-9
`
`Manufacturing
`(CMC)
`
`Letters, Reviews, Labels, Patient Package Insert
`
`06/30/2011
`
`SUPPL-8
`
`Labeling(cid:173)
`Package Insert
`
`Label (PDF)
`(https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020645s0081bl.pdt)
`Letter (PDF)
`(https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020645s0081tr.pdt)
`
`Showing 1 to 3 of 3 entries
`
`Labels for NDA 020645
`
`Therapeutic Equivalents for NDA 020645
`
`Note
`
`Label is
`not
`available
`on this
`site.
`
`Label is
`not
`available
`on this
`site.
`
`v
`
`v
`
`https://www.accessdata.fda.gov/scripts/cder/daflinclex.cfm?event=BasicSearch.process
`
`212
`
`Par Pharmaceutical, Inc. Ex. 1031
`Par v. Horizon, IPR of Patent No. 9,561,197
`Page 2 of 2
`
`