FDA.reportPublic FDA data

Application 020547

Type
NDA
Sponsor
PAR PHARM INC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001ACCOLATEZAFIRLUKASTTABLET;ORAL20MGYesYes
003ACCOLATEZAFIRLUKASTTABLET;ORAL10MGYesNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0904-6646ZafirlukastzafirlukastMajor PharmaceuticalsNDACurrent
0904-6646ZafirlukastzafirlukastMajor PharmaceuticalsNDACurrent
49884-010ACCOLATEzafirlukastPar Pharmaceutical Inc.NDACurrent
49884-010ACCOLATEzafirlukastPar Pharmaceutical Inc.NDACurrent
49884-011ACCOLATEzafirlukastPar Pharmaceutical Inc.NDACurrent
49884-549ZafirlukastzafirlukastPar Pharmaceutical, Inc.NDACurrent
49884-549ZafirlukastzafirlukastPar Pharmaceutical, Inc.NDACurrent
49884-549ZafirlukastzafirlukastPar Pharmaceutical, Inc.NDACurrent
49884-549ZafirlukastzafirlukastPar Pharmaceutical, Inc.NDACurrent
49884-554ZafirlukastzafirlukastPar Pharmaceutical, Inc.NDACurrent
49884-554ZafirlukastzafirlukastPar Pharmaceutical, Inc.NDACurrent
49884-554ZafirlukastzafirlukastPar Pharmaceutical, Inc.NDACurrent
49884-554ZafirlukastzafirlukastPar Pharmaceutical, Inc.NDACurrent
49884-589AccolatezafirlukastPar Pharmaceutical, Inc.NDACurrent
49884-589AccolatezafirlukastPar Pharmaceutical, Inc.NDACurrent
49884-589AccolatezafirlukastPar Pharmaceutical, Inc.NDACurrent
49884-589AccolatezafirlukastPar Pharmaceutical, Inc.NDACurrent
49884-590AccolatezafirlukastPar Pharmaceutical, Inc.NDACurrent
49884-590AccolatezafirlukastPar Pharmaceutical, Inc.NDACurrent
49884-590AccolatezafirlukastPar Pharmaceutical, Inc.NDACurrent
49884-590AccolatezafirlukastPar Pharmaceutical, Inc.NDACurrent
53808-0203ACCOLATEZafirlukastState of Florida DOH Central PharmacyNDACurrent
63629-2102ZafirlukastzafirlukastBryant Ranch PrepackNDACurrent
63629-2102ZafirlukastzafirlukastBryant Ranch PrepackNDACurrent
63629-2102ZafirlukastzafirlukastBryant Ranch PrepackNDACurrent
64380-177ACCOLATEZafirlukastStrides Pharma Science LimitedNDACurrent
64380-178ACCOLATEZafirlukastStrides Pharma Science LimitedNDACurrent
64380-187ZafirlukastzafirlukastStrides Pharma Science LimitedNDACurrent
64380-187ZafirlukastzafirlukastStrides Pharma Science LimitedNDACurrent
64380-188ZafirlukastzafirlukastStrides Pharma Science LimitedNDACurrent
64380-188ZafirlukastzafirlukastStrides Pharma Science LimitedNDACurrent
64380-188ZafirlukastzafirlukastStrides Pharma Science LimitedNDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
34809SUPPL2013-11-22
25152SUPPL2013-11-18
25151SUPPL2011-08-10
12709SUPPL2011-08-08
34808SUPPL2010-10-19
2702SUPPL2010-10-19
12708SUPPL2010-07-19
25150SUPPL2010-07-15
2701SUPPL2009-11-19
12707SUPPL2009-08-28
25149SUPPL2008-06-02
34807SUPPL2005-06-08
25148SUPPL2005-06-08
41421SUPPL2004-05-25
25147SUPPL2004-05-25
20712SUPPL2004-05-25
20711SUPPL2004-04-14
34806SUPPL2004-04-05
2700SUPPL2003-07-29
2699SUPPL1999-09-17
57448ORIG1997-04-10