Theophylline Extended Release Oral Capsule

Brand(s)
Theo-24
Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Actient Pharmaceuticals, Llc (2014-12-17)
Oldest Current Product
1983-08-22
License(s)
ANDA
RxNORM
EXTENDED RELEASE ORAL CAPSULE\THEOPHYLLINE
FDAOB
ORAL\CAPSULE, EXTENDED RELEASE\THEOPHYLLINE
SPL Active
ORAL\CAPSULE, EXTENDED RELEASE\THEOPHYLLINE ANHYDROUS
SPL Moiety
ORAL\CAPSULE, EXTENDED RELEASE\THEOPHYLLINE
ORAL\CAPSULE, EXTENDED RELEASE\THEOPHYLLINE ANHYDROUS

product(s) by strength(s)

theophylline 100 mg extended release oral capsule

generic product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1504740100Theo-24ANDAUcb, Inc.1998-04-21THEOPHYLLINE ANHYDROUSORALCAPSULE, EXTENDED RELEASEANDA087942fde7e9b2-c2d8-47bb-abe1-ec987da951ab
2522440100Theo-24ANDAActient Pharmaceuticals, Llc2014-08-25THEOPHYLLINE ANHYDROUSORALCAPSULE, EXTENDED RELEASEANDA0879427a108fa0-c230-475f-be93-6f864b98a410

theophylline 200 mg extended release oral capsule

generic product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1504740200Theo-24ANDAUcb, Inc.1998-01-20THEOPHYLLINE ANHYDROUSORALCAPSULE, EXTENDED RELEASEANDA087943fde7e9b2-c2d8-47bb-abe1-ec987da951ab
2522440200Theo-24ANDAActient Pharmaceuticals, Llc2014-08-25THEOPHYLLINE ANHYDROUSORALCAPSULE, EXTENDED RELEASEANDA0879437a108fa0-c230-475f-be93-6f864b98a410

theophylline 300 mg extended release oral capsule

generic product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1504740300Theo-24ANDAUcb, Inc.1998-02-20THEOPHYLLINE ANHYDROUSORALCAPSULE, EXTENDED RELEASEANDA087944fde7e9b2-c2d8-47bb-abe1-ec987da951ab
2522440300Theo-24ANDAActient Pharmaceuticals, Llc2014-08-25THEOPHYLLINE ANHYDROUSORALCAPSULE, EXTENDED RELEASEANDA0879447a108fa0-c230-475f-be93-6f864b98a410

relabeler product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1551547206Theo-24ANDACardinal Health1983-08-22THEOPHYLLINE ANHYDROUSORALCAPSULE, EXTENDED RELEASE504740300ANDA087944f24f8e9c-ac46-4101-9250-9005af0edf72

theophylline 400 mg extended release oral capsule

generic product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1504740400Theo-24ANDAUcb, Inc.1998-01-09THEOPHYLLINE ANHYDROUSORALCAPSULE, EXTENDED RELEASEANDA081034fde7e9b2-c2d8-47bb-abe1-ec987da951ab
2522440400Theo-24ANDAActient Pharmaceuticals, Llc2014-08-25THEOPHYLLINE ANHYDROUSORALCAPSULE, EXTENDED RELEASEANDA0810347a108fa0-c230-475f-be93-6f864b98a410

application(s)

#idtitledeprecatedapplicantapprovedapproved drug
1ANDA040052THEOPHYLLINETrueINWOOD LABORATORIES INC SUB FOREST LABORATORIES INC1994-02-14ANDA040052_001, ANDA040052_002, ANDA040052_003, ANDA040052_004
2ANDA081034THEO-24ACTIENT PHARMACEUTICALS LLC1992-02-28ANDA081034_001
3ANDA085075AEROLATE IIITrueFLEMING AND CO PHARMACEUTICALS INC1986-11-24ANDA085075_001, ANDA085075_002, ANDA085075_003
4ANDA085203SLO-PHYLLINTrueSANOFI AVENTIS US LLC1982-05-24ANDA085203_001
5ANDA085205SLO-PHYLLINTrueSANOFI AVENTIS US LLC1982-05-24ANDA085205_001
6ANDA085206SLO-PHYLLINTrueSANOFI AVENTIS US LLC1982-05-24ANDA085206_001
7ANDA085983THEOBIDTrueWHITBY PHARMACEUTICALS INC1985-03-20ANDA085983_001
8ANDA086471THEOPHYL-SRTrueORTHO MCNEIL PHARMACEUTICAL INC1985-02-08ANDA086471_001
9ANDA086480THEOPHYL-SRTrueORTHO MCNEIL PHARMACEUTICAL INC1985-02-08ANDA086480_001
10ANDA086569THEOCLEAR L.A.-130TrueSCHWARZ PHARMA INC1982-05-27ANDA086569_001, ANDA086569_002
11ANDA086826ELIXOPHYLLIN SRTrueFOREST LABORATORIES INC1985-01-29ANDA086826_001, ANDA086826_002
12ANDA087010THEOVENTTrueSCHERING CORP SUB SCHERING PLOUGH CORP1985-01-31ANDA087010_001
13ANDA087193SOMOPHYLLIN-CRTTrueDM GRAHAM LABORATORIES INCANDA087193_001
14ANDA087194SOMOPHYLLIN-CRTTrueDM GRAHAM LABORATORIES INCANDA087194_001
15ANDA087462THEOPHYLLINETrueSANDOZ INC1982-05-11ANDA087462_001
16ANDA087763SOMOPHYLLIN-CRTTrueDM GRAHAM LABORATORIES INC1985-02-27ANDA087763_001
17ANDA087854THEOBID JR.TrueWHITBY PHARMACEUTICALS INC1985-03-20ANDA087854_001
18ANDA087892SLO-BIDTrueSANOFI AVENTIS US LLC1985-01-31ANDA087892_001
19ANDA087893SLO-BIDTrueSANOFI AVENTIS US LLC1985-01-31ANDA087893_001
20ANDA087894SLO-BIDTrueSANOFI AVENTIS US LLC1985-01-31ANDA087894_001
21ANDA087910THEOVENTTrueSCHERING CORP SUB SCHERING PLOUGH CORP1985-01-31ANDA087910_001
22ANDA087942THEO-24ACTIENT PHARMACEUTICALS LLC1983-08-22ANDA087942_001
23ANDA087943THEO-24ACTIENT PHARMACEUTICALS LLC1983-08-22ANDA087943_001
24ANDA087944THEO-24ACTIENT PHARMACEUTICALS LLC1983-08-22ANDA087944_001
25ANDA087995THEO-DURTrueSCHERING CORP1985-09-10ANDA087995_001
26ANDA088015THEO-DURTrueSCHERING CORP1985-09-10ANDA088015_001
27ANDA088016THEO-DURTrueSCHERING CORP1985-09-10ANDA088016_001
28ANDA088022THEO-DURTrueSCHERING CORP1985-09-10ANDA088022_001
29ANDA088255THEOPHYLLINE-SRTrueRP SCHERER NORTH AMERICA DIV RP SCHERER CORP1986-06-12ANDA088255_001
30ANDA088269SLO-BIDTrueSANOFI AVENTIS US LLC1985-01-31ANDA088269_001
31ANDA088382SOMOPHYLLIN-CRTTrueDM GRAHAM LABORATORIES INC1985-02-27ANDA088382_001
32ANDA088383SOMOPHYLLIN-CRTTrueDM GRAHAM LABORATORIES INC1985-02-27ANDA088383_001
33ANDA088654THEOPHYLLINETrueCENTRAL PHARMACEUTICALS INC1985-02-12ANDA088654_001
34ANDA088689THEOPHYLLINETrueCENTRAL PHARMACEUTICALS INC1985-02-12ANDA088689_001
35ANDA089539SLO-BIDTrueSANOFI AVENTIS US LLC1989-05-10ANDA089539_001
36ANDA089540SLO-BIDTrueSANOFI AVENTIS US LLC1989-05-10ANDA089540_001
37ANDA089932THEOPHYLLINETrueHOSPIRA INC1995-01-04ANDA089932_001
38ANDA089976THEOPHYLLINETrueHOSPIRA INC1995-01-04ANDA089976_001
39ANDA089977THEOPHYLLINETrueHOSPIRA INC1995-01-04ANDA089977_001

application drug(s)

#idcategory/deprecatedingredient strength(s)routedose formrldapprovedapplication
1ANDA040052_001discontinuedTHEOPHYLLINE (100MG)ORALCAPSULE, EXTENDED RELEASEFalse1994-02-14THEOPHYLLINE
2ANDA040052_002discontinuedTHEOPHYLLINE (125MG)ORALCAPSULE, EXTENDED RELEASEFalse1994-02-14THEOPHYLLINE
3ANDA040052_003discontinuedTHEOPHYLLINE (200MG)ORALCAPSULE, EXTENDED RELEASEFalse1994-02-14THEOPHYLLINE
4ANDA040052_004discontinuedTHEOPHYLLINE (300MG)ORALCAPSULE, EXTENDED RELEASEFalse1994-02-14THEOPHYLLINE
5ANDA081034_001RXTHEOPHYLLINE (400MG)ORALCAPSULE, EXTENDED RELEASETrue1992-02-28THEO-24
6ANDA085075_001discontinuedTHEOPHYLLINE (260MG)ORALCAPSULE, EXTENDED RELEASEFalse1986-11-24AEROLATE III
7ANDA085075_002discontinuedTHEOPHYLLINE (130MG)ORALCAPSULE, EXTENDED RELEASEFalse1986-11-24AEROLATE III
8ANDA085075_003discontinuedTHEOPHYLLINE (65MG)ORALCAPSULE, EXTENDED RELEASEFalse1986-11-24AEROLATE III
9ANDA085203_001discontinuedTHEOPHYLLINE (125MG)ORALCAPSULE, EXTENDED RELEASEFalse1982-05-24SLO-PHYLLIN
10ANDA085205_001discontinuedTHEOPHYLLINE (250MG)ORALCAPSULE, EXTENDED RELEASEFalse1982-05-24SLO-PHYLLIN
11ANDA085206_001discontinuedTHEOPHYLLINE (60MG)ORALCAPSULE, EXTENDED RELEASEFalse1982-05-24SLO-PHYLLIN
12ANDA085983_001discontinuedTHEOPHYLLINE (260MG)ORALCAPSULE, EXTENDED RELEASEFalse1985-03-20THEOBID
13ANDA086471_001discontinuedTHEOPHYLLINE (250MG)ORALCAPSULE, EXTENDED RELEASEFalse1985-02-08THEOPHYL-SR
14ANDA086480_001discontinuedTHEOPHYLLINE (125MG)ORALCAPSULE, EXTENDED RELEASEFalse1985-02-08THEOPHYL-SR
15ANDA086569_001discontinuedTHEOPHYLLINE (130MG)ORALCAPSULE, EXTENDED RELEASEFalse1982-05-27THEOCLEAR L.A.-130
16ANDA086569_002discontinuedTHEOPHYLLINE (260MG)ORALCAPSULE, EXTENDED RELEASEFalse1982-05-27THEOCLEAR L.A.-130
17ANDA086826_001discontinuedTHEOPHYLLINE (125MG)ORALCAPSULE, EXTENDED RELEASEFalse1985-01-29ELIXOPHYLLIN SR
18ANDA086826_002discontinuedTHEOPHYLLINE (250MG)ORALCAPSULE, EXTENDED RELEASEFalse1985-01-29ELIXOPHYLLIN SR
19ANDA087010_001discontinuedTHEOPHYLLINE (125MG)ORALCAPSULE, EXTENDED RELEASEFalse1985-01-31THEOVENT
20ANDA087193_001discontinuedTHEOPHYLLINE (250MG)ORALCAPSULE, EXTENDED RELEASEFalseSOMOPHYLLIN-CRT
21ANDA087194_001discontinuedTHEOPHYLLINE (100MG)ORALCAPSULE, EXTENDED RELEASEFalseSOMOPHYLLIN-CRT
22ANDA087462_001discontinuedTHEOPHYLLINE (260MG)ORALCAPSULE, EXTENDED RELEASEFalse1982-05-11THEOPHYLLINE
23ANDA087763_001discontinuedTHEOPHYLLINE (50MG)ORALCAPSULE, EXTENDED RELEASEFalse1985-02-27SOMOPHYLLIN-CRT
24ANDA087854_001discontinuedTHEOPHYLLINE (130MG)ORALCAPSULE, EXTENDED RELEASEFalse1985-03-20THEOBID JR.
25ANDA087892_001discontinuedTHEOPHYLLINE (100MG)ORALCAPSULE, EXTENDED RELEASEFalse1985-01-31SLO-BID
26ANDA087893_001discontinuedTHEOPHYLLINE (200MG)ORALCAPSULE, EXTENDED RELEASEFalse1985-01-31SLO-BID
27ANDA087894_001discontinuedTHEOPHYLLINE (300MG)ORALCAPSULE, EXTENDED RELEASEFalse1985-01-31SLO-BID
28ANDA087910_001discontinuedTHEOPHYLLINE (250MG)ORALCAPSULE, EXTENDED RELEASEFalse1985-01-31THEOVENT
29ANDA087942_001RXTHEOPHYLLINE (100MG)ORALCAPSULE, EXTENDED RELEASEFalse1983-08-22THEO-24
30ANDA087943_001RXTHEOPHYLLINE (200MG)ORALCAPSULE, EXTENDED RELEASEFalse1983-08-22THEO-24
31ANDA087944_001RXTHEOPHYLLINE (300MG)ORALCAPSULE, EXTENDED RELEASEFalse1983-08-22THEO-24
32ANDA087995_001discontinuedTHEOPHYLLINE (200MG)ORALCAPSULE, EXTENDED RELEASEFalse1985-09-10THEO-DUR
33ANDA088015_001discontinuedTHEOPHYLLINE (75MG)ORALCAPSULE, EXTENDED RELEASEFalse1985-09-10THEO-DUR
34ANDA088016_001discontinuedTHEOPHYLLINE (125MG)ORALCAPSULE, EXTENDED RELEASEFalse1985-09-10THEO-DUR
35ANDA088022_001discontinuedTHEOPHYLLINE (50MG)ORALCAPSULE, EXTENDED RELEASEFalse1985-09-10THEO-DUR
36ANDA088255_001discontinuedTHEOPHYLLINE (300MG)ORALCAPSULE, EXTENDED RELEASEFalse1986-06-12THEOPHYLLINE-SR
37ANDA088269_001discontinuedTHEOPHYLLINE (50MG)ORALCAPSULE, EXTENDED RELEASEFalse1985-01-31SLO-BID
38ANDA088382_001discontinuedTHEOPHYLLINE (200MG)ORALCAPSULE, EXTENDED RELEASEFalse1985-02-27SOMOPHYLLIN-CRT
39ANDA088383_001discontinuedTHEOPHYLLINE (300MG)ORALCAPSULE, EXTENDED RELEASEFalse1985-02-27SOMOPHYLLIN-CRT
40ANDA088654_001discontinuedTHEOPHYLLINE (125MG)ORALCAPSULE, EXTENDED RELEASEFalse1985-02-12THEOPHYLLINE
41ANDA088689_001discontinuedTHEOPHYLLINE (250MG)ORALCAPSULE, EXTENDED RELEASEFalse1985-02-12THEOPHYLLINE
42ANDA089539_001discontinuedTHEOPHYLLINE (75MG)ORALCAPSULE, EXTENDED RELEASEFalse1989-05-10SLO-BID
43ANDA089540_001discontinuedTHEOPHYLLINE (125MG)ORALCAPSULE, EXTENDED RELEASEFalse1989-05-10SLO-BID
44ANDA089932_001discontinuedTHEOPHYLLINE (300MG)ORALCAPSULE, EXTENDED RELEASEFalse1995-01-04THEOPHYLLINE
45ANDA089976_001discontinuedTHEOPHYLLINE (100MG)ORALCAPSULE, EXTENDED RELEASEFalse1995-01-04THEOPHYLLINE
46ANDA089977_001discontinuedTHEOPHYLLINE (200MG)ORALCAPSULE, EXTENDED RELEASEFalse1995-01-04THEOPHYLLINE

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)
17a108fa0-c230-475f-be93-6f864b98a410 (view SPL)Theo-24 (theophylline anhydrous) Extended-release capsules 100, 200, 300, & 400 mgprescriptionHuman PrescriptionActient Pharmaceuticals, LlcANALYSIS, API MANUFACTURE, LABEL, MANUFACTURE, PACK2014-12-173522440100, 522440200, 522440300, 522440400
2f24f8e9c-ac46-4101-9250-9005af0edf72 (view SPL)Theo-24 (theophylline anhydrous) Extended-release capsules 100, 200, 300, & 400 mgprescriptionHuman PrescriptionCardinal HealthREPACK2010-12-071551547206
3fde7e9b2-c2d8-47bb-abe1-ec987da951ab (view SPL)Theo-24 (theophylline anhydrous) Extended-release capsules 100, 200, 300, & 400 mgprescriptionHuman PrescriptionUcb, Inc.2012-08-213504740100, 504740200, 504740300, 504740400

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