Albuterol Extended Release Oral Tablet

Brand(s)
Vospire
Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Dava Pharmaceuticals, Inc. (2013-01-08)
Oldest Current Product
2002-09-30
License(s)
ANDA
RxNORM
EXTENDED RELEASE ORAL TABLET\ALBUTEROL
FDAOB
ORAL\TABLET, EXTENDED RELEASE\ALBUTEROL SULFATE
SPL Active
ORAL\TABLET, EXTENDED RELEASE\ALBUTEROL SULFATE
ORAL\TABLET, FILM COATED, EXTENDED RELEASE\ALBUTEROL SULFATE
SPL Moiety
ORAL\TABLET, EXTENDED RELEASE\ALBUTEROL
ORAL\TABLET, FILM COATED, EXTENDED RELEASE\ALBUTEROL

product(s) by strength(s)

12 hr albuterol 4 mg extended release oral tablet

generic product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1003784122ANDAMylan Pharmaceuticals Inc.2007-01-30ALBUTEROL SULFATEORALTABLET, FILM COATED, EXTENDED RELEASEANDA07809299d6ba1a-1599-48a3-8dbd-a8b06af20fe1
2687740400ANDADava Pharmaceuticals, Inc.2002-09-30ALBUTEROL SULFATEORALTABLET, EXTENDED RELEASEANDA076130e0ec9932-b2a3-4776-a7e8-2aeded019da4
3687740600VospireANDADava Pharmaceuticals, Inc.2002-09-30ALBUTEROL SULFATEORALTABLET, EXTENDED RELEASEANDA07613016efdd16-04db-4874-92de-d1de22aee074

12 hr albuterol 8 mg extended release oral tablet

generic product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1003784124ANDAMylan Pharmaceuticals Inc.2007-01-30ALBUTEROL SULFATEORALTABLET, FILM COATED, EXTENDED RELEASEANDA07809299d6ba1a-1599-48a3-8dbd-a8b06af20fe1
2687740401ANDADava Pharmaceuticals, Inc.2002-09-30ALBUTEROL SULFATEORALTABLET, EXTENDED RELEASEANDA076130e0ec9932-b2a3-4776-a7e8-2aeded019da4
3687740601VospireANDADava Pharmaceuticals, Inc.2002-09-30ALBUTEROL SULFATEORALTABLET, EXTENDED RELEASEANDA07613016efdd16-04db-4874-92de-d1de22aee074

application(s)

#idtitledeprecatedapplicantapprovedapproved drug
1ANDA076130VOSPIRE ERDAVA PHARMACEUTICALS INC2002-09-26ANDA076130_002, ANDA076130_003
2ANDA078092ALBUTEROL SULFATEMYLAN PHARMACEUTICALS INC2007-01-29ANDA078092_001, ANDA078092_002
3NDA019383PROVENTILTrueSCHERING CORP SUB SCHERING PLOUGH CORP1987-07-13NDA019383_001
4NDA019604VOLMAXTrueMURO PHARMACEUTICAL INC1992-12-23NDA019604_001, NDA019604_002

application drug(s)

#idcategory/deprecatedingredient strength(s)routedose formrldTEapprovedapplication
1ANDA076130_002RXALBUTEROL SULFATE (EQ 4MG BASE)ORALTABLET, EXTENDED RELEASEFalseAB2002-09-26VOSPIRE ER
2ANDA076130_003RXALBUTEROL SULFATE (EQ 8MG BASE)ORALTABLET, EXTENDED RELEASETrueAB2002-09-26VOSPIRE ER
3ANDA078092_001RXALBUTEROL SULFATE (EQ 8MG BASE)ORALTABLET, EXTENDED RELEASEFalseAB2007-01-29ALBUTEROL SULFATE
4ANDA078092_002RXALBUTEROL SULFATE (EQ 4MG BASE)ORALTABLET, EXTENDED RELEASEFalseAB2007-01-29ALBUTEROL SULFATE
5NDA019383_001discontinuedALBUTEROL SULFATE (EQ 4MG BASE)ORALTABLET, EXTENDED RELEASEFalse1987-07-13PROVENTIL
6NDA019604_001discontinuedALBUTEROL SULFATE (EQ 8MG BASE)ORALTABLET, EXTENDED RELEASEFalse1992-12-23VOLMAX
7NDA019604_002discontinuedALBUTEROL SULFATE (EQ 4MG BASE)ORALTABLET, EXTENDED RELEASEFalse1992-12-23VOLMAX

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)
116efdd16-04db-4874-92de-d1de22aee074 (view SPL)VoSpire ER (Albuterol Sulfate) Extended-Release TabletsprescriptionHuman PrescriptionDava Pharmaceuticals, Inc.ANALYSIS, API MANUFACTURE, LABEL, MANUFACTURE, PACK2013-01-082687740600, 687740601
299d6ba1a-1599-48a3-8dbd-a8b06af20fe1 (view SPL)prescriptionHuman PrescriptionMylan Pharmaceuticals Inc.2015-03-316003784122, 003784124
3e0ec9932-b2a3-4776-a7e8-2aeded019da4 (view SPL)Albuterol Sulfate Extended-Release TabletsprescriptionHuman PrescriptionDava Pharmaceuticals, Inc.ANALYSIS, API MANUFACTURE, LABEL, MANUFACTURE, PACK2013-01-082687740400, 687740401

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