Dyphylline Oral Tablet

Brand(s)
Lufyllin
Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Meda Pharmaceuticals Inc. (2015-01-12)
Oldest Current Product
1976-08-31
License(s)
ANDA
RxNORM
ORAL TABLET\DYPHYLLINE
FDAOB
ORAL\ELIXIR\DYPHYLLINE
ORAL\TABLET\DYPHYLLINE
SPL Active
ORAL\TABLET\DYPHYLLINE
SPL Moiety
ORAL\TABLET\DYPHYLLINE

product(s) by strength(s)

dyphylline 200 mg oral tablet

generic product(s)(s)

#idbrandcategorylabelerfirst marketedlast marketedactive ingredient(s)routedose formapplicationspl
1000370521LufyllinANDAMeda Pharmaceuticals Inc.1976-08-312016-02-29DYPHYLLINEORALTABLETANDA0845666d7ed7c0-9646-11de-a404-0002a5d5c51b

dyphylline 400 mg oral tablet

generic product(s)(s)

#idbrandcategorylabelerfirst marketedlast marketedactive ingredient(s)routedose formapplicationspl
1000370731LufyllinANDAMeda Pharmaceuticals Inc.1976-08-312015-01-31DYPHYLLINEORALTABLETANDA0845666d7ed7c0-9646-11de-a404-0002a5d5c51b

application(s)

#idtitledeprecatedapplicantapproved drug
1ANDA084514DILORTrueSAVAGE LABORATORIES INC DIV ALTANA INCANDA084514_001
2ANDA084566LUFYLLINMEDA PHARMACEUTICALS INCANDA084566_001, ANDA084566_002
3ANDA084751DILOR-400TrueSAVAGE LABORATORIES INC DIV ALTANA INCANDA084751_001
4NDA007794NEOTHYLLINETrueTEVA PHARMACEUTICALS USA INCNDA007794_001, NDA007794_002, NDA007794_003

application drug(s)

#idcategory/deprecatedingredient strength(s)routedose formrldapplication
1ANDA084514_001discontinuedDYPHYLLINE (200MG)ORALTABLETFalseDILOR
2ANDA084566_001RXDYPHYLLINE (200MG)ORALTABLETFalseLUFYLLIN
3ANDA084566_002RXDYPHYLLINE (400MG)ORALTABLETTrueLUFYLLIN
4ANDA084751_001discontinuedDYPHYLLINE (400MG)ORALTABLETFalseDILOR-400
5NDA007794_001discontinuedDYPHYLLINE (200MG)ORALTABLETFalseNEOTHYLLINE
6NDA007794_002discontinuedDYPHYLLINE (400MG)ORALTABLETFalseNEOTHYLLINE
7NDA007794_003discontinuedDYPHYLLINE (160MG/15ML)ORALELIXIRFalseNEOTHYLLINE

spl(s)

#idtitlecategorytypelabelerlast updateversionproduct(s)
16d7ed7c0-9646-11de-a404-0002a5d5c51b (view SPL)Lufyllin (dyphylline tablets, USP, 200 mg) Lufyllin-400(dyphylline tablets, USP, 400 mg) IN-0521-11Rev. 1/09prescriptionHuman PrescriptionMeda Pharmaceuticals Inc.2015-01-124000370521, 000370731

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