Theophylline Oral Solution

Brand(s)
Elixophyllin
Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Silarx Pharmaceuticals, Inc (2014-06-27)
Oldest Current Product
2008-11-03
License(s)
ANDA
RxNORM
ORAL SOLUTION\THEOPHYLLINE
FDAOB
ORAL\SOLUTION, ELIXIR\THEOPHYLLINE\rdfq
ORAL\SOLUTION\THEOPHYLLINE
SPL Active
ORAL\LIQUID\THEOPHYLLINE ANHYDROUS
ORAL\SOLUTION\THEOPHYLLINE ANHYDROUS
SPL Moiety
ORAL\LIQUID\THEOPHYLLINE ANHYDROUS
ORAL\SOLUTION\THEOPHYLLINE ANHYDROUS

product(s) by strength(s)

theophylline 5.33 mg/ml oral solution

generic product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1278080033ANDATris Pharma Inc2012-08-02THEOPHYLLINE ANHYDROUSORALSOLUTIONANDA09158678a99bfe-6ebe-4ace-80b0-ee019921435e
2497080644ElixophyllinANDACaraco Pharma, Inc.2009-10-01THEOPHYLLINE ANHYDROUSORALLIQUIDANDA0851862676f761-4fe5-40a9-a07d-ed2542847883
3518620131ANDALibertas Pharma, Inc.2013-05-03THEOPHYLLINE ANHYDROUSORALSOLUTIONANDA0915865c6ec629-4c68-4d1b-9c82-db09ead1ab83
4548380556ANDASilarx Pharmaceuticals, Inc2011-04-13THEOPHYLLINE ANHYDROUSORALSOLUTIONANDA09115625b2fdbe-2f18-4153-835a-7a67bff83ef8
5606210033ANDACranbury Pharmaceuticals Inc2014-11-03THEOPHYLLINE ANHYDROUSORALSOLUTIONANDA0915866ec9b686-2602-47a0-8491-58b9a9d029ee

relabeler product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1001214794ANDAPharmaceutical Associates, Inc.2008-11-03THEOPHYLLINE ANHYDROUSORALSOLUTION497080644ANDA085186c248b178-951c-4710-933b-d9a6a8555688
2178560644ElixophyllinANDAAtlantic Biologicals Corps2009-10-01THEOPHYLLINE ANHYDROUSORALLIQUID497080644ANDA0851867a5a367f-8461-4b15-99fc-f89aa7d5936e

application(s)

#idtitledeprecatedapplicantapprovedapproved drug
1ANDA085186ELIXOPHYLLINSUN PHARMACEUTICAL INDUSTRIES INCANDA085186_001
2ANDA086107THEOLAIRTrue3M PHARMACEUTICALS INCANDA086107_001
3ANDA087449THEOPHYLLINETrueROXANE LABORATORIES INC1983-09-15ANDA087449_001
4ANDA089141AEROLATETrueFLEMING AND CO PHARMACEUTICALS INC1986-12-03ANDA089141_001
5ANDA091156THEOPHYLLINESILARX PHARMACEUTICALS INC2011-04-13ANDA091156_001
6ANDA091586THEOPHYLLINETRIS PHARMA INC2012-06-15ANDA091586_001

application drug(s)

#idcategory/deprecatedingredient strength(s)routedose formrldTEapprovedapplication
1ANDA085186_001RXTHEOPHYLLINE (80MG/15ML)ORALTrueELIXOPHYLLIN
2ANDA086107_001discontinuedTHEOPHYLLINE (80MG/15ML)ORALSOLUTIONFalseTHEOLAIR
3ANDA087449_001discontinuedTHEOPHYLLINE (80MG/15ML)ORALSOLUTIONFalse1983-09-15THEOPHYLLINE
4ANDA089141_001discontinuedTHEOPHYLLINE (150MG/15ML)ORALSOLUTIONFalse1986-12-03AEROLATE
5ANDA091156_001RXTHEOPHYLLINE (80MG/15ML)ORALSOLUTIONTrueAA2011-04-13THEOPHYLLINE
6ANDA091586_001RXTHEOPHYLLINE (80MG/15ML)ORALSOLUTIONFalseAA2012-06-15THEOPHYLLINE

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)
125b2fdbe-2f18-4153-835a-7a67bff83ef8 (view SPL)THEOPHYLLINE ORAL SOLUTION, USP 80 mg/ 15 mLprescriptionHuman PrescriptionSilarx Pharmaceuticals, Inc2014-06-279548380556
22676f761-4fe5-40a9-a07d-ed2542847883 (view SPL)Rx OnlyprescriptionHuman PrescriptionCaraco Pharma, Inc.Analysis, Manufacture, Pack2014-03-124497080644
35c6ec629-4c68-4d1b-9c82-db09ead1ab83 (view SPL)Theophylline Oral SolutionprescriptionHuman PrescriptionLibertas Pharma, Inc.MANUFACTURE2013-05-031518620131
46ec9b686-2602-47a0-8491-58b9a9d029ee (view SPL)Theophylline Oral SolutionprescriptionHuman PrescriptionCranbury Pharmaceuticals Inc2014-11-194606210033
578a99bfe-6ebe-4ace-80b0-ee019921435e (view SPL)Theophylline Oral SolutionprescriptionHuman PrescriptionTris Pharma IncANALYSIS, API MANUFACTURE, MANUFACTURE2012-07-271278080033
67a5a367f-8461-4b15-99fc-f89aa7d5936e (view SPL)Rx OnlyprescriptionHuman PrescriptionAtlantic Biologicals CorpsRELABEL, REPACK2010-09-285178560644
7c248b178-951c-4710-933b-d9a6a8555688 (view SPL)THEOPHYLLINE ORAL SOLUTIONprescriptionHuman PrescriptionPharmaceutical Associates, Inc.MANUFACTURE, REPACK2012-08-201001214794

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