Budesonide Inhalant Solution

Brand(s)
Pulmicort
Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Astrazeneca Lp (2010-07-02)
Oldest Current Product
2000-09-08
License(s)
NDA, ANDA
RxNORM
INHALANT SOLUTION\BUDESONIDE
FDAOB
INHALATION\SUSPENSION\BUDESONIDE\rdfq
SPL Active
RESPIRATORY (INHALATION)\INHALANT\BUDESONIDE
RESPIRATORY (INHALATION)\SUSPENSION\BUDESONIDE
SPL Moiety
RESPIRATORY (INHALATION)\INHALANT\BUDESONIDE
RESPIRATORY (INHALATION)\SUSPENSION\BUDESONIDE

product(s) by strength(s)

budesonide 0.125 mg/ml inhalant solution

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1001861988PulmicortNDAAstrazeneca Lp2000-09-08BUDESONIDERESPIRATORY (INHALATION)SUSPENSIONNDA02092933cd9834-76df-4f26-3fa2-aab6b9eee8f2

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1000936815ANDATeva Pharmaceuticals Usa Inc2008-11-19BUDESONIDERESPIRATORY (INHALATION)SUSPENSIONANDA0775192414058b-5d39-42f2-915f-03a5e1101ab5
2005913767ANDAWatson Laboratories, Inc.2013-04-02BUDESONIDERESPIRATORY (INHALATION)SUSPENSIONANDA0784044f339e84-33be-44d1-bbae-e0579da12c7f
3007817515ANDASandoz Inc2015-07-24BUDESONIDERESPIRATORY (INHALATION)SUSPENSIONANDA2019664830c0dd-6964-4108-89bc-3af039612b95

invalid application product(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1004879601ANDANephron Pharmaceuticals Corporation2013-10-01BUDESONIDERESPIRATORY (INHALATION)INHALANTANDA078202f12043df-f9a3-4edb-88f8-dd176c1a141c
2605050820ANDAApotex Corp2009-03-30BUDESONIDERESPIRATORY (INHALATION)SUSPENSIONANDA0782029ca16deb-4390-ed45-a584-280da063b205

relabeler product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1548683423ANDAPhysicians Total Care, Inc.2010-01-19BUDESONIDERESPIRATORY (INHALATION)SUSPENSION000936815ANDA077519ca6ae964-3b4b-4c24-a939-0100791ce1fe
2548685774PulmicortNDAPhysicians Total Care, Inc.2007-06-01BUDESONIDERESPIRATORY (INHALATION)SUSPENSION001861988NDA0209292e0fa140-85a0-42db-ba15-a068120076b4
3687880012ANDAPreferred Pharmaceuticals, Inc.2009-02-04BUDESONIDERESPIRATORY (INHALATION)SUSPENSION000936815ANDA077519214b6a39-9d7f-4c4d-8e40-a5c4ef05c3d8

budesonide 0.25 mg/ml inhalant solution

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1001861989PulmicortNDAAstrazeneca Lp2000-09-08BUDESONIDERESPIRATORY (INHALATION)SUSPENSIONNDA02092933cd9834-76df-4f26-3fa2-aab6b9eee8f2

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1000936816ANDATeva Pharmaceuticals Usa Inc2008-11-19BUDESONIDERESPIRATORY (INHALATION)SUSPENSIONANDA0775192414058b-5d39-42f2-915f-03a5e1101ab5
2005913768ANDAWatson Laboratories, Inc.2013-04-02BUDESONIDERESPIRATORY (INHALATION)SUSPENSIONANDA0784044f339e84-33be-44d1-bbae-e0579da12c7f
3007817516ANDASandoz Inc2015-07-24BUDESONIDERESPIRATORY (INHALATION)SUSPENSIONANDA2019664830c0dd-6964-4108-89bc-3af039612b95

invalid application product(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1004879701ANDANephron Pharmaceuticals Corporation2013-10-01BUDESONIDERESPIRATORY (INHALATION)INHALANTANDA078202f12043df-f9a3-4edb-88f8-dd176c1a141c
2605050821ANDAApotex Corp2009-03-30BUDESONIDERESPIRATORY (INHALATION)SUSPENSIONANDA0782029ca16deb-4390-ed45-a584-280da063b205

relabeler product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1548683550ANDAPhysicians Total Care, Inc.2009-02-04BUDESONIDERESPIRATORY (INHALATION)SUSPENSION000936816ANDA077519ca6ae964-3b4b-4c24-a939-0100791ce1fe
2548685621PulmicortNDAPhysicians Total Care, Inc.2006-06-29BUDESONIDERESPIRATORY (INHALATION)SUSPENSION001861989NDA0209292e0fa140-85a0-42db-ba15-a068120076b4
3551548283ANDACardinal Health2009-12-15BUDESONIDERESPIRATORY (INHALATION)SUSPENSION000936816ANDA077519d70092e2-07e2-4a23-aa6a-0e2444e12ee2
4551549613PulmicortNDACardinal Health2009-11-20BUDESONIDERESPIRATORY (INHALATION)SUSPENSION001861989NDA0209299e6641a9-32c8-422a-a1d6-3aba08fd1400
5682588922ANDADispensing Solutions, Inc.2008-11-19BUDESONIDERESPIRATORY (INHALATION)SUSPENSION000936816ANDA07751978d25104-15c6-499c-a748-b3407cd9738e
6687880013ANDAPreferred Pharmaceuticals, Inc.2009-02-04BUDESONIDERESPIRATORY (INHALATION)SUSPENSION000936816ANDA077519214b6a39-9d7f-4c4d-8e40-a5c4ef05c3d8
7687883768ANDAPreferred Pharmaceuticals, Inc.2015-08-17BUDESONIDERESPIRATORY (INHALATION)SUSPENSION005913768ANDA078404cbec80f7-a85d-475d-bdbd-f940d7faadea

budesonide 0.5 mg/ml inhalant solution

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1001861990PulmicortNDAAstrazeneca Lp2007-09-17BUDESONIDERESPIRATORY (INHALATION)SUSPENSIONNDA02092933cd9834-76df-4f26-3fa2-aab6b9eee8f2

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1007817517ANDASandoz Inc2015-07-24BUDESONIDERESPIRATORY (INHALATION)SUSPENSIONANDA2019664830c0dd-6964-4108-89bc-3af039612b95

application(s)

#idtitledeprecatedapplicantapprovedpatentapproved drug
1ANDA077519BUDESONIDETEVA PHARMACEUTICALS USA2008-11-18ANDA077519_001, ANDA077519_002
2ANDA078202BUDESONIDETrueAPOTEX INC2009-03-30ANDA078202_001, ANDA078202_002
3ANDA078404BUDESONIDEWATSON LABORATORIES INC2012-07-31ANDA078404_001, ANDA078404_002
4ANDA201966BUDESONIDESANDOZ INC2013-09-27ANDA201966_001, ANDA201966_002, ANDA201966_003
5NDA020929PULMICORT RESPULESASTRAZENECA PHARMACEUTICALS LP2000-08-08p6598603, ONCE DAILY TREATMENT OF ASTHMA WITH NEBULIZED BUDESONIDE
p6899099, ONCE DAILY TREATMENT OF ASTHMA WITH NEBULIZED BUDESONIDE
p7524834, TREATMENT OF ASTHMA (MAINTENANCE AND PROPHYLACTIC THERAPY), SUBSTANCE
NDA020929_001, NDA020929_002, NDA020929_003

application drug(s)

#idcategory/deprecatedingredient strength(s)dose formrldTEapprovedapplication
1ANDA077519_001RXBUDESONIDE (0.25MG/2ML)SUSPENSIONFalseAN2008-11-18BUDESONIDE
2ANDA077519_002RXBUDESONIDE (0.5MG/2ML)SUSPENSIONFalseAN2008-11-18BUDESONIDE
3ANDA078202_001discontinuedBUDESONIDE (0.25MG/2ML)SUSPENSIONFalse2009-03-30BUDESONIDE
4ANDA078202_002discontinuedBUDESONIDE (0.5MG/2ML)SUSPENSIONFalse2009-03-30BUDESONIDE
5ANDA078404_001RXBUDESONIDE (0.25MG/2ML)SUSPENSIONFalseAN2012-07-31BUDESONIDE
6ANDA078404_002RXBUDESONIDE (0.5MG/2ML)SUSPENSIONFalseAN2012-07-31BUDESONIDE
7ANDA201966_001RXBUDESONIDE (1MG/2ML)SUSPENSIONFalseAN2013-09-27BUDESONIDE
8ANDA201966_002RXBUDESONIDE (0.5MG/2ML)SUSPENSIONFalseAN2013-09-27BUDESONIDE
9ANDA201966_003RXBUDESONIDE (0.25MG/2ML)SUSPENSIONFalseAN2013-09-27BUDESONIDE
10NDA020929_001RXBUDESONIDE (0.25MG/2ML)SUSPENSIONFalseAN2000-08-08PULMICORT RESPULES
11NDA020929_002RXBUDESONIDE (0.5MG/2ML)SUSPENSIONFalseAN2000-08-08PULMICORT RESPULES
12NDA020929_003RXBUDESONIDE (1MG/2ML)SUSPENSIONTrueAN2000-08-08PULMICORT RESPULES

patent(s)

#idexpiration dateapplication(s)
1p6598603 (view patent)2018-12-23NDA020929
2p6899099 (view patent)2018-12-23NDA020929
3p7524834 (view patent)2018-11-11NDA020929

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)
1214b6a39-9d7f-4c4d-8e40-a5c4ef05c3d8 (view SPL)These highlights do not include all the information needed to use budesonide inhalation suspension safely and effectively. See full prescribing information for budesonide inhalation suspension.BUDESONIDE inhalation suspension Initial U.S. Approval: 2000prescriptionHuman PrescriptionPreferred Pharmaceuticals, Inc.RELABEL2014-10-016687880012, 687880013
22414058b-5d39-42f2-915f-03a5e1101ab5 (view SPL)These highlights do not include all the information needed to use budesonide inhalation suspension safely and effectively. See full prescribing information for budesonide inhalation suspension.BUDESONIDE inhalation suspension Initial U.S. Approval: 2000prescriptionHuman PrescriptionTeva Pharmaceuticals Usa Inc2014-08-158000936815, 000936816
32e0fa140-85a0-42db-ba15-a068120076b4 (view SPL)These highlights do not include all the information needed to use PULMICORT RESPULES safely and effectively. See full prescribing information for PULMICORT RESPULES . PULMICORT RESPULES (BUDESONIDE INHALATION SUSPENSION)INITIAL U.S. APPROVAL 2000prescriptionHuman PrescriptionPhysicians Total Care, Inc.relabel2012-06-042548685621, 548685774
433cd9834-76df-4f26-3fa2-aab6b9eee8f2 (view SPL)These highlights do not include all the information needed to use PULMICORT RESPULES safely and effectively. See full prescribing information for PULMICORT RESPULES . PULMICORT RESPULES (budesonide) INHALATION SUSPENSION Initial U.S. Approval: 2000prescriptionHuman PrescriptionAstrazeneca LpMANUFACTURE, RELABEL, REPACK2010-07-0214001861988, 001861989, 001861990
54830c0dd-6964-4108-89bc-3af039612b95 (view SPL)These highlights do not include all the information needed to use budesonide inhalation suspension safely and effectively. See full prescribing information for budesonide inhalation suspension. Budesonide Inhalation SuspensionFor inhalation onlyInitial U.S. Approval: 2000prescriptionHuman PrescriptionSandoz Inc2015-07-241007817515, 007817516, 007817517
64f339e84-33be-44d1-bbae-e0579da12c7f (view SPL)These highlights do not include all the information needed to use budesonide inhalation suspension safely and effectively. See full prescribing information for budesonide inhalation suspension . BUDESONIDE INHALATION SUSPENSION Initial U.S. Approval: 2000prescriptionHuman PrescriptionWatson Laboratories, Inc.ANALYSIS, MANUFACTURE2011-04-018005913767, 005913768
778d25104-15c6-499c-a748-b3407cd9738e (view SPL)These highlights do not include all the information needed to use budesonide inhalation suspension safely and effectively. See full prescribing information for budesonide inhalation suspension.BUDESONIDE inhalation suspension Initial U.S. Approval: 2000prescriptionHuman PrescriptionDispensing Solutions, Inc.relabel, repack2013-08-301682588922
89ca16deb-4390-ed45-a584-280da063b205 (view SPL)These highlights do not include all the information needed to use safely and effectively. See full prescribing information for Budesonide Inhalation Suspension. Budesonide Inhalation Suspension, for inhalation suspension Initial U.S. Approval: 2000prescriptionHuman PrescriptionApotex Corpanalysis, manufacture2013-07-012605050820, 605050821
99e6641a9-32c8-422a-a1d6-3aba08fd1400 (view SPL)These highlights do not include all the information needed to use PULMICORT RESPULES safely and effectively. See full prescribing information for PULMICORT RESPULES . PULMICORT RESPULES (BUDESONIDE INHALATION SUSPENSION). INITIAL U.S. APPROVAL: 2000prescriptionHuman PrescriptionCardinal HealthREPACK2012-06-203551549613
10ca6ae964-3b4b-4c24-a939-0100791ce1fe (view SPL)These highlights do not include all the information needed to use budesonide inhalation suspension safely and effectively. See full prescribing information for budesonide inhalation suspension.BUDESONIDE inhalation suspension Initial U.S. Approval: 2000prescriptionHuman PrescriptionPhysicians Total Care, Inc.relabel2012-04-162548683423, 548683550
11cbec80f7-a85d-475d-bdbd-f940d7faadea (view SPL)These highlights do not include all the information needed to use budesonide inhalation suspension safely and effectively. See full prescribing information for budesonide inhalation suspension.BUDESONIDE INHALATION SUSPENSIONInitial U.S. Approval: 2000prescriptionHuman PrescriptionPreferred Pharmaceuticals, Inc.RELABEL2015-09-173687883768
12d70092e2-07e2-4a23-aa6a-0e2444e12ee2 (view SPL)These highlights do not include all the information needed to use budesonide inhalation suspension safely and effectively. See full prescribing information for budesonide inhalation suspension.BUDESONIDE inhalation suspension Initial U.S. Approval: 2000prescriptionHuman PrescriptionCardinal HealthREPACK2013-04-055551548283
13f12043df-f9a3-4edb-88f8-dd176c1a141c (view SPL)These highlights do not include all the information needed to use safely and effectively. See full prescribing information for Budesonide Inhalation Suspension. Budesonide Inhalation Suspension, for inhalation suspension Initial U.S. Approval: 2000prescriptionHuman PrescriptionNephron Pharmaceuticals CorporationANALYSIS, MANUFACTURE2013-10-081004879601, 004879701

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