Albuterol Oral Tablet

Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Mylan Pharmaceuticals Inc. (2010-01-04)
Oldest Current Product
1989-12-05
License(s)
ANDA
RxNORM
ORAL TABLET\ALBUTEROL
FDAOB
ORAL\TABLET\ALBUTEROL SULFATE
SPL Active
ORAL\TABLET\ALBUTEROL SULFATE
SPL Moiety
ORAL\TABLET\ALBUTEROL

product(s) by strength(s)

albuterol 2 mg oral tablet

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1003780255ANDAMylan Pharmaceuticals Inc.1991-01-17ALBUTEROL SULFATEORALTABLETANDA0728941c1f3881-2b68-4bdb-a12f-8134fe8ba961
2534890176ANDAMutual Pharmaceutical Company, Inc.1989-12-05ALBUTEROL SULFATEORALTABLETANDA07263787b8cd3c-2849-4b50-b63e-9ea379165c07

relabeler product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1510790657ANDAMylan Institutional Inc.1997-04-29ALBUTEROL SULFATEORALTABLET003780255ANDA0728942e7c1e97-b8b2-44c0-aeac-18f9142a522b
2521250235ANDARemedyrepack Inc.2013-03-06ALBUTEROL SULFATEORALTABLET534890176ANDA072637a7c031a5-3bf8-4548-8fe7-0c308a45152a
3521250281ANDARemedyrepack Inc.2013-05-07ALBUTEROL SULFATEORALTABLET534890176ANDA072637708615b8-79b1-4eaa-b765-abb01be3233a
4548681073ANDAPhysicians Total Care, Inc.1993-08-13ALBUTEROL SULFATEORALTABLET534890176ANDA072637b49edc01-1ea6-4f88-883a-bb4bc2bf4b3f
5636292638ANDABryant Ranch Prepack1989-12-05ALBUTEROL SULFATEORALTABLET534890176ANDA0726377fe2669f-ca2a-fd31-e09c-fd2819a8308c
6680840949ANDAAmerican Health Packaging2015-09-01ALBUTEROL SULFATEORALTABLET534890176ANDA072637b0f73459-baeb-42a7-be48-2c3647d9b205
7687880255ANDAPreferred Pharmaceuticals, Inc.1989-12-05ALBUTEROL SULFATEORALTABLET534890176ANDA072637d8f090fb-c591-4d6a-98b7-925b0bb17c38

albuterol 4 mg oral tablet

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1003780572ANDAMylan Pharmaceuticals Inc.1991-01-17ALBUTEROL SULFATEORALTABLETANDA0728941c1f3881-2b68-4bdb-a12f-8134fe8ba961
2534890177ANDAMutual Pharmaceutical Company, Inc.1989-12-05ALBUTEROL SULFATEORALTABLETANDA07263787b8cd3c-2849-4b50-b63e-9ea379165c07

relabeler product(s)(s)

#idcategorylabelerfirst marketedlast marketedactive ingredient(s)routedose formequivalent productapplicationspl
1510790658ANDAMylan Institutional Inc.1997-04-29ALBUTEROL SULFATEORALTABLET003780572ANDA0728942e7c1e97-b8b2-44c0-aeac-18f9142a522b
2548681074ANDAPhysicians Total Care, Inc.1994-11-232012-06-30ALBUTEROL SULFATEORALTABLET534890177ANDA072637b49edc01-1ea6-4f88-883a-bb4bc2bf4b3f
3552890045ANDAPd-Rx Pharmaceuticals, Inc.2011-05-04ALBUTEROL SULFATEORALTABLET003780572ANDA0728943e95d573-74b2-4b0e-9397-c2cdaf7f41e5
4636292736ANDABryant Ranch Prepack1989-12-05ALBUTEROL SULFATEORALTABLET534890177ANDA07263742bfd443-1d9d-4806-b044-6ff874b92b25
5680840952ANDAAmerican Health Packaging2015-09-01ALBUTEROL SULFATEORALTABLET534890177ANDA072637b0f73459-baeb-42a7-be48-2c3647d9b205
6687880177ANDAPreferred Pharmaceuticals, Inc.1989-12-05ALBUTEROL SULFATEORALTABLET534890177ANDA072637d8f090fb-c591-4d6a-98b7-925b0bb17c38

application(s)

#idtitledeprecatedapplicantapprovedapproved drug
1ANDA072151ALBUTEROL SULFATETrueSANDOZ INC1989-12-05ANDA072151_001
2ANDA072152ALBUTEROL SULFATETrueSANDOZ INC1989-12-05ANDA072152_001
3ANDA072316ALBUTEROL SULFATETruePLIVA INC1989-12-05ANDA072316_001
4ANDA072317ALBUTEROL SULFATETruePLIVA INC1989-12-05ANDA072317_001
5ANDA072449ALBUTEROL SULFATETrueAMERICAN THERAPEUTICS INC1989-12-05ANDA072449_001
6ANDA072450ALBUTEROL SULFATETrueAMERICAN THERAPEUTICS INC1989-12-05ANDA072450_001
7ANDA072619ALBUTEROL SULFATETrueTEVA PHARMACEUTICALS USA INC1989-12-05ANDA072619_001
8ANDA072620ALBUTEROL SULFATETrueTEVA PHARMACEUTICALS USA INC1989-12-05ANDA072620_001
9ANDA072629ALBUTEROL SULFATETrueWATSON LABORATORIES INC1991-01-31ANDA072629_001
10ANDA072630ALBUTEROL SULFATETrueWATSON LABORATORIES INC1991-01-31ANDA072630_001
11ANDA072637ALBUTEROL SULFATEMUTUAL PHARMACEUTICAL CO INC1989-12-05ANDA072637_001, ANDA072637_002
12ANDA072764ALBUTEROL SULFATETrueWATSON LABORATORIES INC1991-08-28ANDA072764_001
13ANDA072765ALBUTEROL SULFATETrueWATSON LABORATORIES INC1991-08-28ANDA072765_001
14ANDA072779ALBUTEROL SULFATETrueTEVA PHARMACEUTICALS USA INC1993-06-25ANDA072779_001
15ANDA072780ALBUTEROL SULFATETrueTEVA PHARMACEUTICALS USA INC1993-06-25ANDA072780_001
16ANDA072817ALBUTEROL SULFATETrueWARNER CHILCOTT DIV WARNER LAMBERT CO1990-01-09ANDA072817_001
17ANDA072818ALBUTEROL SULFATETrueWARNER CHILCOTT DIV WARNER LAMBERT CO1990-01-09ANDA072818_001
18ANDA072859ALBUTEROL SULFATETrueDAVA PHARMACEUTICALS INC1989-12-20ANDA072859_001
19ANDA072860ALBUTEROL SULFATETrueDAVA PHARMACEUTICALS INC1989-12-20ANDA072860_001
20ANDA072894ALBUTEROL SULFATEMYLAN PHARMACEUTICALS INC1991-01-17ANDA072894_001, ANDA072894_002
21ANDA072938ALBUTEROL SULFATETrueTEVA PHARMACEUTICALS USA INC1990-03-30ANDA072938_001
22ANDA072939ALBUTEROL SULFATETrueTEVA PHARMACEUTICALS USA INC1990-03-30ANDA072939_001
23ANDA072966ALBUTEROL SULFATETrueCOPLEY PHARMACEUTICAL INC1991-11-22ANDA072966_001
24ANDA072967ALBUTEROL SULFATETrueCOPLEY PHARMACEUTICAL INC1991-11-22ANDA072967_001
25ANDA073120ALBUTEROL SULFATETrueUCB INC1992-09-29ANDA073120_001
26ANDA073121ALBUTEROL SULFATETrueUCB INC1992-09-29ANDA073121_001
27NDA017853PROVENTILTrueSCHERING CORP SUB SCHERING PLOUGH CORP1982-05-07NDA017853_001, NDA017853_002
28NDA019112VENTOLINTrueGLAXOSMITHKLINE1986-07-10NDA019112_001, NDA019112_002

application drug(s)

#idcategory/deprecatedingredient strength(s)routedose formrldTEapprovedapplication
1ANDA072151_001discontinuedALBUTEROL SULFATE (EQ 2MG BASE)ORALTABLETFalse1989-12-05ALBUTEROL SULFATE
2ANDA072152_001discontinuedALBUTEROL SULFATE (EQ 4MG BASE)ORALTABLETFalse1989-12-05ALBUTEROL SULFATE
3ANDA072316_001discontinuedALBUTEROL SULFATE (EQ 2MG BASE)ORALTABLETFalse1989-12-05ALBUTEROL SULFATE
4ANDA072317_001discontinuedALBUTEROL SULFATE (EQ 4MG BASE)ORALTABLETFalse1989-12-05ALBUTEROL SULFATE
5ANDA072449_001discontinuedALBUTEROL SULFATE (EQ 2MG BASE)ORALTABLETFalse1989-12-05ALBUTEROL SULFATE
6ANDA072450_001discontinuedALBUTEROL SULFATE (EQ 4MG BASE)ORALTABLETFalse1989-12-05ALBUTEROL SULFATE
7ANDA072619_001discontinuedALBUTEROL SULFATE (EQ 2MG BASE)ORALTABLETFalse1989-12-05ALBUTEROL SULFATE
8ANDA072620_001discontinuedALBUTEROL SULFATE (EQ 4MG BASE)ORALTABLETFalse1989-12-05ALBUTEROL SULFATE
9ANDA072629_001discontinuedALBUTEROL SULFATE (EQ 2MG BASE)ORALTABLETFalse1991-01-31ALBUTEROL SULFATE
10ANDA072630_001discontinuedALBUTEROL SULFATE (EQ 4MG BASE)ORALTABLETFalse1991-01-31ALBUTEROL SULFATE
11ANDA072637_001RXALBUTEROL SULFATE (EQ 4MG BASE)ORALTABLETFalseAB1989-12-05ALBUTEROL SULFATE
12ANDA072637_002RXALBUTEROL SULFATE (EQ 2MG BASE)ORALTABLETFalseAB1989-12-05ALBUTEROL SULFATE
13ANDA072764_001discontinuedALBUTEROL SULFATE (EQ 2MG BASE)ORALTABLETFalse1991-08-28ALBUTEROL SULFATE
14ANDA072765_001discontinuedALBUTEROL SULFATE (EQ 4MG BASE)ORALTABLETFalse1991-08-28ALBUTEROL SULFATE
15ANDA072779_001discontinuedALBUTEROL SULFATE (EQ 2MG BASE)ORALTABLETFalse1993-06-25ALBUTEROL SULFATE
16ANDA072780_001discontinuedALBUTEROL SULFATE (EQ 4MG BASE)ORALTABLETFalse1993-06-25ALBUTEROL SULFATE
17ANDA072817_001discontinuedALBUTEROL SULFATE (EQ 2MG BASE)ORALTABLETFalse1990-01-09ALBUTEROL SULFATE
18ANDA072818_001discontinuedALBUTEROL SULFATE (EQ 4MG BASE)ORALTABLETFalse1990-01-09ALBUTEROL SULFATE
19ANDA072859_001discontinuedALBUTEROL SULFATE (EQ 2MG BASE)ORALTABLETFalse1989-12-20ALBUTEROL SULFATE
20ANDA072860_001discontinuedALBUTEROL SULFATE (EQ 4MG BASE)ORALTABLETFalse1989-12-20ALBUTEROL SULFATE
21ANDA072894_001RXALBUTEROL SULFATE (EQ 4MG BASE)ORALTABLETTrueAB1991-01-17ALBUTEROL SULFATE
22ANDA072894_002RXALBUTEROL SULFATE (EQ 2MG BASE)ORALTABLETFalseAB1991-01-17ALBUTEROL SULFATE
23ANDA072938_001discontinuedALBUTEROL SULFATE (EQ 2MG BASE)ORALTABLETFalse1990-03-30ALBUTEROL SULFATE
24ANDA072939_001discontinuedALBUTEROL SULFATE (EQ 4MG BASE)ORALTABLETFalse1990-03-30ALBUTEROL SULFATE
25ANDA072966_001discontinuedALBUTEROL SULFATE (EQ 2MG BASE)ORALTABLETFalse1991-11-22ALBUTEROL SULFATE
26ANDA072967_001discontinuedALBUTEROL SULFATE (EQ 4MG BASE)ORALTABLETFalse1991-11-22ALBUTEROL SULFATE
27ANDA073120_001discontinuedALBUTEROL SULFATE (EQ 2MG BASE)ORALTABLETFalse1992-09-29ALBUTEROL SULFATE
28ANDA073121_001discontinuedALBUTEROL SULFATE (EQ 4MG BASE)ORALTABLETFalse1992-09-29ALBUTEROL SULFATE
29NDA017853_001discontinuedALBUTEROL SULFATE (EQ 2MG BASE)ORALTABLETFalse1982-05-07PROVENTIL
30NDA017853_002discontinuedALBUTEROL SULFATE (EQ 4MG BASE)ORALTABLETFalse1982-05-07PROVENTIL
31NDA019112_001discontinuedALBUTEROL SULFATE (EQ 2MG BASE)ORALTABLETFalse1986-07-10VENTOLIN
32NDA019112_002discontinuedALBUTEROL SULFATE (EQ 4MG BASE)ORALTABLETFalse1986-07-10VENTOLIN

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)
11c1f3881-2b68-4bdb-a12f-8134fe8ba961 (view SPL)prescriptionHuman PrescriptionMylan Pharmaceuticals Inc.2010-01-045003780255, 003780572
22e7c1e97-b8b2-44c0-aeac-18f9142a522b (view SPL)prescriptionHuman PrescriptionMylan Institutional Inc.2015-07-032510790657, 510790658
33e95d573-74b2-4b0e-9397-c2cdaf7f41e5 (view SPL)prescriptionHuman PrescriptionPd-Rx Pharmaceuticals, Inc.repack2010-01-042552890045
442bfd443-1d9d-4806-b044-6ff874b92b25 (view SPL)ALBUTEROL TABLETS USPprescriptionHuman PrescriptionBryant Ranch PrepackRELABEL, REPACK2013-02-131000636292736
5708615b8-79b1-4eaa-b765-abb01be3233a (view SPL)ALBUTEROL TABLETS USPprescriptionHuman PrescriptionRemedyrepack Inc.2013-05-071521250281
67fe2669f-ca2a-fd31-e09c-fd2819a8308c (view SPL)ALBUTEROL TABLETS USPprescriptionHuman PrescriptionBryant Ranch PrepackRELABEL, REPACK1989-12-051636292638
787b8cd3c-2849-4b50-b63e-9ea379165c07 (view SPL)ALBUTEROL TABLETS USPprescriptionHuman PrescriptionMutual Pharmaceutical Company, Inc.2014-07-013534890176, 534890177
8a7c031a5-3bf8-4548-8fe7-0c308a45152a (view SPL)ALBUTEROL TABLETS USPprescriptionHuman PrescriptionRemedyrepack Inc.2013-03-061521250235
9b0f73459-baeb-42a7-be48-2c3647d9b205 (view SPL)ALBUTEROL TABLETS USPprescriptionHuman PrescriptionAmerican Health PackagingREPACK2015-08-131680840949, 680840952
10b49edc01-1ea6-4f88-883a-bb4bc2bf4b3f (view SPL)ALBUTEROL TABLETS USPprescriptionHuman PrescriptionPhysicians Total Care, Inc.relabel, repack2012-10-243548681073, 548681074
11d8f090fb-c591-4d6a-98b7-925b0bb17c38 (view SPL)ALBUTEROL TABLETS USPprescriptionHuman PrescriptionPreferred Pharmaceuticals, Inc.REPACK2014-09-243687880177, 687880255

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