Regulatory PathRegulatory requirements compared

Active substance

Theophylline

Open in the medicines table

SFDA Saudi Arabia — SFDA human drug list

Trade nameStrengthForm · routePackPublic priceTypeCompanyStatus
RIAPHYLLIN 60MG/5ML SYRUP12 mg/mlSyrup · Oral use1 BottleSAR 18.65Generic · PrescriptionRIYADH PHARMAValid
THEO-DUR TAB 200MG200 mgProlonged-release tablet · Oral use30 BlisterSAR 12.85Generic · PrescriptionRECORDATIValid
THEO-DUR TAB 300MG300 mgProlonged-release tablet · Oral use30 BlisterSAR 15.55Generic · PrescriptionRECORDATIValid
AVOLEN 60MG-5ML SYRUP12 mg/mlSyrup · Oral use1 BottleSAR 8.30Generic · PrescriptionTabuk Pharmaceutical Manufacturing CompanyWithdrawn by MAH · Not Marketed
AVOLEN S.R TABLET300 mgTablet · Oral use30 BlisterSAR 15.40Generic · PrescriptionTabuk Pharmaceutical Manufacturing CompanyWithdrawn by MAH · Not Marketed
EUPHYLLIN AMP 0.24GM-10ML I.V24 mg/mlInjection · Intravenous use5 AmpouleSAR 14.15NCE · PrescriptionNYCOMEDWithdrawn by MAH · Not Marketed
EUPHYLLINE RETARD C.TAB 250MG250 mgFilm-coated tablet · Oral use20 BlisterSAR 22.45NCE · PrescriptionTAKEDA GMBHWithdrawn by MAH · Not Marketed
EUPHYLLINE RTD.MITE C.TAB 175MG175 mgCoated tablet · Oral use20 BlisterSAR 17.40NCE · PrescriptionNYCOMEDWithdrawn by MAH · Not Marketed
RIAPHYLLIN 300MG SR TABLET300 mgProlonged-release tablet · Oral use30 BlisterSAR 17.15Generic · PrescriptionRIYADH PHARMAWithdrawn by MAH · Not Marketed
THEOPHAR 100 MG S.R CAPSULES100 mgProlonged-release capsule · Oral use30 BlisterSAR 4.50Generic · PrescriptionGulf Pharmaceutical Industries (Julphar)Withdrawn by MAH · Not Marketed
THEOPHAR 200 MG S.R CAPSULES200 mgProlonged-release capsule · Oral use20 BlisterSAR 4.50Generic · PrescriptionGulf Pharmaceutical Industries (Julphar)Withdrawn by MAH · Not Marketed
THEOPHAR 300 MG S.R CAPSULES300 mgProlonged-release capsule · Oral use10 BlisterSAR 4.50Generic · PrescriptionGulf Pharmaceutical Industries (Julphar)Withdrawn by MAH · Not Marketed
THEOPHAR 60MG-5ML SYRUP12 mg/mlSyrup · Oral use1 BottleSAR 8.30Generic · PrescriptionGulf Pharmaceutical Industries (Julphar)Withdrawn by MAH · Not Marketed
Indications — CHI Daman Drug Formulary

BRADYCARDIA; CHRONIC OBSTRUCTIVE PULMONARY DISEASE (COPD); SICKLE CELL DISEASE - ACS MANAGEMENT

US FDA United States — FDA approvals (Drugs@FDA)

ProductStrengthForm · routeApplicantStatusFirst approved
THEOPHYLLINE300MG; 100MG; 200MG; 450MGtablet, extended release · oralNOSTRUM PHARMS LLCPrescription11 Jan 1983
THEO-24200MG; 100MG; 300MG; 400MGcapsule, extended release · oralENDO OPERATIONSPrescription22 Aug 1983
THEOPHYLLINE300MGtablet, extended release · oralHERITAGE PHARMA AVETPrescription30 Apr 1990
THEOPHYLLINE450MGtablet, extended release · oralHERITAGE PHARMA AVETPrescription9 Nov 1992
THEOPHYLLINE400MGtablet, extended release · oralRHODES PHARMSPrescription15 Apr 1996
THEOPHYLLINE600MG; 400MGtablet, extended release · oralMPP PHARMAPrescription21 Apr 2006
THEOPHYLLINE400MG; 600MGtablet, extended release · oralGLENMARK PHARMS LTDPrescription13 Jul 2010
THEOPHYLLINE300MG; 450MGtablet, extended release · oralALEMBICPrescription27 Oct 2010
THEOPHYLLINE80MG/15MLsolution · oralCHARTWELL MOLECULARPrescription13 Apr 2011
THEOPHYLLINE80MG/15MLsolution · oralTRIS PHARMA INCPrescription15 Jun 2012
THEOPHYLLINE80MG/15MLsolution, elixir · oralPHARM ASSOCPrescription16 Dec 2016
THEOPHYLLINE300MG; 450MGtablet, extended release · oralGLENMARK PHARMS LTDPrescription3 Jun 2021
THEOPHYLLINE300MG; 450MGtablet, extended release · oralTEVA PHARMS INCPrescription12 Oct 2022
THEOPHYLLINE300MG; 450MGtablet, extended release · oralVELZEN PHARMA PVTPrescription30 Jan 2023
THEOPHYLLINE300MG; 450MGtablet, extended release · oralAMNEALPrescription20 Mar 2023
THEOPHYLLINE300MG; 450MGtablet, extended release · oralBIONPHARMAPrescription26 Apr 2023
THEOPHYLLINE300MG; 450MGtablet, extended release · oralANNORA PHARMAPrescription8 Sep 2023
THEOPHYLLINE300MG; 450MGtablet, extended release · oralHARMAN FINOCHEMPrescription24 Oct 2023
THEOPHYLLINE300MG; 450MGtablet, extended release · oralZYDUS LIFESCIENCESPrescription21 May 2024
THEOPHYLLINE300MG; 450MGtablet, extended release · oralSTRIDES PHARMAPrescription5 Sep 2024
LANOPHYLLIN80MG/15MLelixir · oralLANNETTDiscontinued26 Jul 1976
ELIXOPHYLLIN80MG/15MLsolution, elixir · oralSOLIS PHARMSDiscontinued26 Jan 1979
THEOPHYLLINE80MG/15MLelixir · oralHALSEYDiscontinued8 Feb 1979
THEOPHYLLINE80MG/15MLelixir · oralPRECISION DOSEDiscontinued16 Mar 1979
THEOLAIR80MG/15MLsolution · oral3MDiscontinued26 Mar 1979

110 more — full table

Canada Canada — marketed products (Health Canada)

BrandDINStrengthForm · routeCompany
AA-THEO LA00692689100 MGTABLET (EXTENDED-RELEASE) · ORALAA PHARMA INC
AA-THEO LA00692697200 MGTABLET (EXTENDED-RELEASE) · ORALAA PHARMA INC
AA-THEO LA00692700300 MGTABLET (EXTENDED-RELEASE) · ORALAA PHARMA INC
ELIXIR DE THEOPHYLLINE0062741080 MG / 15 MLELIXIR · ORALLABORATOIRE ATLAS INC
THEO ER02360101400 MGTABLET (EXTENDED-RELEASE) · ORALAA PHARMA INC
THEO ER02360128600 MGTABLET (EXTENDED-RELEASE) · ORALAA PHARMA INC

Prices — United States and England

SourceProduct as listedPriceUnit / packDate
US NADACTHEOPHYLLINE 80 MG/15 ML SOLN$0.11183per ML19 Aug 2026
US NADACTHEOPHYLLINE ER 300 MG TABLET$0.32954per EA23 Sep 2026
US NADACTHEOPHYLLINE ER 400 MG TABLET$0.99526per EA23 Sep 2026
US NADACTHEOPHYLLINE ER 450 MG TABLET$1.09918per EA23 Sep 2026
US NADACTHEOPHYLLINE ER 600 MG TABLET$1.39516per EA14 Jan 2026
NHS Drug TariffTheophylline 200mg modified-release tablets£35.6556 tablet1 Oct 2026
NHS Drug TariffTheophylline 300mg modified-release tablets£35.6556 tablet1 Oct 2026
NHS Drug TariffTheophylline 400mg modified-release tablets£35.6556 tablet1 Oct 2026

NADAC: average price US retail pharmacies pay to buy the medicine. NHS Drug Tariff Part VIIIA: basic price reimbursed to pharmacies in England and Wales.

Combinations containing Theophylline

Values as published by each source: SFDA human drug list (4-2026, as published by the Council of Health Insurance; indications from the CHI Daman Drug Formulary), Drugs@FDA, EMA medicines data, Health Canada Drug Product Database (Open Government Licence – Canada), CMS NADAC, NHS Drug Tariff Part VIIIA (NHSBSA Copyright, Open Government Licence v3.0), WHO Model List of Essential Medicines (CC BY 3.0 IGO; regrouped by active substance, not created by WHO), EMA PRAC, US FDA safety-related labeling changes and MHRA Drug Safety Update (Open Government Licence v3.0). Sources and reuse. Not a substitute for the official registers or the product information.