zafirlukast Oral Tablet

Brand(s)
Accolate
Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Par Pharmaceutical Companies, Inc. (2015-01-12)
Oldest Current Product
1996-10-01
License(s)
NDA, ANDA
RxNORM
ORAL TABLET\ZAFIRLUKAST
FDAOB
ORAL\TABLET\ZAFIRLUKAST
SPL Active
ORAL\TABLET, FILM COATED\ZAFIRLUKAST
SPL Moiety
ORAL\TABLET, FILM COATED\ZAFIRLUKAST

product(s) by strength(s)

zafirlukast 10 mg oral tablet

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1498840010AccolateNDAPar Pharmaceutical Companies, Inc.2015-01-09ZAFIRLUKASTORALTABLET, FILM COATEDNDA02054747ad879f-77c0-4955-a5a1-783aaa19d59f
2498840303NDAPar Pharmaceutical Companies, Inc.2010-12-01ZAFIRLUKASTORALTABLET, FILM COATEDNDA0205473ed40801-2d03-4609-bda8-ac2be6350333

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1551110625ANDADr. Reddy'S Laboratories Ltd2010-11-18ZAFIRLUKASTORALTABLET, FILM COATEDANDA0903726ccb96af-2647-9206-5eee-49a825d32488

zafirlukast 20 mg oral tablet

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1003100402AccolateNDAAstrazeneca Pharmaceuticals Lp1996-10-01ZAFIRLUKASTORALTABLET, FILM COATEDNDA0205475550433b-8c9c-4378-058f-6bb724c4f18c
2498840304NDAPar Pharmaceutical Companies, Inc.2010-12-01ZAFIRLUKASTORALTABLET, FILM COATEDNDA0205473ed40801-2d03-4609-bda8-ac2be6350333

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1551110626ANDADr. Reddy'S Laboratories Ltd2010-11-18ZAFIRLUKASTORALTABLET, FILM COATEDANDA0903726ccb96af-2647-9206-5eee-49a825d32488

relabeler product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1538080203AccolateNDAState Of Florida Doh Central Pharmacy2009-07-01ZAFIRLUKASTORALTABLET, FILM COATED003100402NDA0205474bf90772-58d5-456d-ad1c-fc448cc5a231
2680840059ANDAAmerican Health Packaging2013-06-07ZAFIRLUKASTORALTABLET, FILM COATED551110626ANDA090372a60f39f6-d590-4b00-8751-7f12b7ec5385
3681511977ANDACarilion Materials Management2010-11-18ZAFIRLUKASTORALTABLET, FILM COATED551110626ANDA090372fb546f57-cd2f-4cbf-8c54-fbc23d47fe0f

application(s)

#idtitleapplicantapprovedapproved drug
1ANDA090372ZAFIRLUKASTDR REDDYS LABORATORIES LTD2010-11-18ANDA090372_001, ANDA090372_002
2NDA020547ACCOLATEPAR PHARMACEUTICAL INC1996-09-26NDA020547_001, NDA020547_003

application drug(s)

#idcategory/deprecatedingredient strength(s)routedose formrldTEapprovedapplication
1ANDA090372_001RXZAFIRLUKAST (10MG)ORALTABLETFalseAB2010-11-18ZAFIRLUKAST
2ANDA090372_002RXZAFIRLUKAST (20MG)ORALTABLETFalseAB2010-11-18ZAFIRLUKAST
3NDA020547_001RXZAFIRLUKAST (20MG)ORALTABLETTrueAB1996-09-26ACCOLATE
4NDA020547_003RXZAFIRLUKAST (10MG)ORALTABLETFalseAB1999-09-17ACCOLATE

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)
13ed40801-2d03-4609-bda8-ac2be6350333 (view SPL)ZAFIRLUKAST TabletsprescriptionHuman PrescriptionPar Pharmaceutical Companies, Inc.2010-10-055498840303, 498840304
247ad879f-77c0-4955-a5a1-783aaa19d59f (view SPL)ACCOLATE (zafirlukast) TABLETSprescriptionHuman PrescriptionPar Pharmaceutical Companies, Inc.MANUFACTURE2015-01-121498840010, 498840011
34bf90772-58d5-456d-ad1c-fc448cc5a231 (view SPL)ACCOLATE(zafirlukast)TABLETSprescriptionHuman PrescriptionState Of Florida Doh Central Pharmacyrepack2010-05-181538080203
45550433b-8c9c-4378-058f-6bb724c4f18c (view SPL)ACCOLATE (zafirlukast) TABLETSprescriptionHuman PrescriptionAstrazeneca Pharmaceuticals LpMANUFACTURE2013-11-1511003100402, 003100401
56ccb96af-2647-9206-5eee-49a825d32488 (view SPL)ZAFIRLUKASTTABLETSprescriptionHuman PrescriptionDr. Reddy'S Laboratories Ltdanalysis, manufacture2010-10-214551110625, 551110626
6a60f39f6-d590-4b00-8751-7f12b7ec5385 (view SPL)ZAFIRLUKAST TABLETSprescriptionHuman PrescriptionAmerican Health PackagingREPACK2015-08-052680840059
7f3f653dd-c8c2-45d8-53b0-c103ac6b878c (view SPL)ZAFIRLUKAST TabletsprescriptionHuman PrescriptionAstrazeneca Pharmaceuticals Lp2010-10-056003100411, 003100412
8fb546f57-cd2f-4cbf-8c54-fbc23d47fe0f (view SPL)ZAFIRLUKAST TABLETSprescriptionHuman PrescriptionCarilion Materials ManagementREPACK2010-10-212681511977

Data from: FDAOB, FDAPB, LOINC, MTHSPL, NDFRT, NCIT, RxNORM, UNII