Ribavirin Oral Tablet

Brand(s)
Copegus, Moderiba, Ribasphere
Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Richmond Pharmaceuticals (2015-05-07)
Oldest Current Product
2005-12-05
License(s)
ANDA
RxNORM
ORAL TABLET\RIBAVIRIN
FDAOB
ORAL\CAPSULE\RIBAVIRIN
ORAL\TABLET\RIBAVIRIN
SPL Active
ORAL\TABLET, COATED\RIBAVIRIN
ORAL\TABLET, FILM COATED\RIBAVIRIN
ORAL\TABLET\RIBAVIRIN
SPL Moiety
ORAL\TABLET, COATED\RIBAVIRIN
ORAL\TABLET, FILM COATED\RIBAVIRIN
ORAL\TABLET\RIBAVIRIN

product(s) by strength(s)

ribavirin 200 mg oral tablet

original product(s)(s)

#idlabeleractive ingredient(s)routedose formspl
1007815177Sandoz IncRIBAVIRINORALTABLET, FILM COATEDd58e820b-bfd2-4e66-9db4-03b526553c93

generic product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1000743197ModeribaANDAAbbvie Inc.2014-01-20RIBAVIRINORALTABLET, FILM COATEDANDA0774567046ff4c-8a75-5fd4-d40f-ff0cc84eed5f
2000937232ANDATeva Pharmaceuticals Usa Inc2005-12-05RIBAVIRINORALTABLET, COATEDANDA077053b600c2f8-f252-4f8f-92f5-922ac52bc341
3547380950ANDARichmond Pharmaceuticals2008-06-01RIBAVIRINORALTABLET, FILM COATEDANDA0774563fc68fa7-3441-478f-a094-5afb7cdecd1f
4658410046ANDACadila Healthcare Limited2005-12-05RIBAVIRINORALTABLET, FILM COATEDANDA077094666e8b22-f519-460b-a774-88a621d56139
5658620207ANDAAurobindo Pharma Limited2009-09-17RIBAVIRINORALTABLET, FILM COATEDANDA079111eee304d0-c2ea-44f4-97d9-92a414d31b6c
6664350102RibasphereANDAKadmon Pharmaceuticals, Llc2005-12-05RIBAVIRINORALTABLET, FILM COATEDANDA07745612f3dec1-4299-4b93-8013-6fa6a963fd81
7683820046ANDAZydus Pharmaceuticals (Usa) Inc.2005-12-05RIBAVIRINORALTABLET, FILM COATEDANDA07709408992c51-8fe9-4d37-85cc-42ff337bda00

relabeler product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1493490829RibasphereANDARemedyrepack Inc.2011-11-30RIBAVIRINORALTABLET664350102ANDA076203bfab78e9-ca51-4ae7-87fa-924d6ca5608a
2538080782ANDAState Of Florida Doh Central Pharmacy2009-07-01RIBAVIRINORALTABLET, FILM COATED683820260ANDA07722414d74b63-34ca-4897-bfdd-3e3952ab6088

ribavirin 400 mg oral tablet

generic product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1547380951ANDARichmond Pharmaceuticals2008-06-01RIBAVIRINORALTABLET, FILM COATEDANDA0774563fc68fa7-3441-478f-a094-5afb7cdecd1f
2664350103RibasphereANDAKadmon Pharmaceuticals, Llc2005-12-05RIBAVIRINORALTABLET, FILM COATEDANDA07745612f3dec1-4299-4b93-8013-6fa6a963fd81

relabeler product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1493490486RibasphereANDARemedyrepack Inc.2011-08-18RIBAVIRINORALTABLET664350103ANDA077456cf7cf753-b35a-4f04-8dbe-f2cf8e229eec

ribavirin 600 mg oral tablet

generic product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1547380952ANDARichmond Pharmaceuticals2008-06-01RIBAVIRINORALTABLET, FILM COATEDANDA0774563fc68fa7-3441-478f-a094-5afb7cdecd1f
2664350104RibasphereANDAKadmon Pharmaceuticals, Llc2005-12-05RIBAVIRINORALTABLET, FILM COATEDANDA07745612f3dec1-4299-4b93-8013-6fa6a963fd81

application(s)

#idtitledeprecatedapplicantapprovedpatentexclusivityapproved drugin other drug docs
1ANDA076192RIBAVIRINSANDOZ INC2004-04-06ANDA076192_001Ribavirin Oral Capsule
2ANDA076203RIBASPHERETHREE RIVERS PHARMACEUTICALS LLC2004-04-06ANDA076203_001Ribavirin Oral Capsule
3ANDA076277RIBAVIRINTEVA PHARMACEUTICALS USA INC2004-10-04ANDA076277_001Ribavirin Oral Capsule
4ANDA077053RIBAVIRINTEVA PHARMACEUTICALS USA INC2005-12-05ANDA077053_001
5ANDA077094RIBAVIRINZYDUS PHARMACEUTICALS USA INC2005-12-05ANDA077094_001, ANDA077094_002, ANDA077094_003, ANDA077094_004
6ANDA077224RIBAVIRINZYDUS PHARMACEUTICALS USA INC2005-10-28ANDA077224_001Ribavirin Oral Capsule
7ANDA077456RIBAVIRINTHREE RIVERS PHARMACEUTICALS LLC2005-12-05ANDA077456_001, ANDA077456_002, ANDA077456_003
8ANDA077743RIBAVIRINSANDOZ INC2006-10-03ANDA077743_001
9ANDA079111RIBAVIRINAUROBINDO PHARMA LTD2009-09-17ANDA079111_001
10ANDA079117RIBAVARINAUROBINDO PHARMA LTD2009-09-17ANDA079117_001Ribavirin Oral Capsule
11ANDA202546RIBAVIRINSANDOZ INC2014-08-12ANDA202546_001, ANDA202546_002, ANDA202546_003, ANDA202546_004
12NDA020903REBETOLTrueMERCK SHARP AND DOHME CORP1998-06-03p6177074, METHOD OF USING RIBAVIRIN IN COMBINATION WITH PEGYLATED INTERFERON ALPHA-2B TO TREAT PATIENTS WITH CHRONIC HEPATITIS C/ METHOD OF TX A PT SUSPECTED OF HAVING HEPATITIS C BY ADMIN
p6172046, METHOD OF USING RIBAVIRIN IN COMBINATION WITH INTERFERON ALPHA-2B(PEGYLATED AND NONPEGYLATED) TO TREAT PATIENTS WITH CHRONIC HEPATITIS C/ METHOD OF TREATING PT WITH CHRONIC HEPATITIS C HAVING HCV GENOTYPE 1 AND VIRAL LOAD GREATER THAN 2 MILLION COPIES/ML TO ERADICATE DETECTABLE HCV-RNA BY ADMIN COMBINATION OF RIBAVIRIN AND INTERFERON ALFA-2B FOR A LEAST 24 WEEKS
p6524570, METHOD OF USING RIBAVIRIN IN COMBINATION WITH PEGYLATED INTERFERON ALPHA-2B TO TREAT PATIENTS WITH CHRONIC HEPATITIS C/ METHOD OF USING REBETOL CAPSULES IN COMBINATION WITH A CONJUGATE COMPRISING POLYETHYLENE GLYCOL(PEG) AND AN ALPHA INTERFERON
p6461605, METHOD OF USING RIBAVIRIN IN COMBINATION WITH PEGYLATED INTERFERON ALPHA-2B TO TREAT PATIENTS WITH CHRONIC HEPATITIS C/ METHOD OF TREATING HEPATITIS C VIRAL INFECTION BY CONTINUOUS PARENTERAL ADMIN INTERFERON ALPHA 2-10 MILLION IU WEEKLY
p6472373, METHOD OF USING RIBAVIRIN IN COMBINATION WITH INTERFERON ALPHA-2B(PEGYLATED AND NONPEGYLATED) TO TREAT PATIENTS WITH CHRONIC HEPATITIS C/ METHOD OF USING PEG-INTRON/REBETOL COMBINATION THERAPY AND INTRON/REBETOL COMBINATION THERAPY
NDA020903_001Ribavirin Oral Capsule
13NDA021511COPEGUSHOFFMANN LA ROCHE INC2002-12-03NEW PATIENT POPULATION [2014-08-09]NDA021511_001, NDA021511_002

application drug(s)

#idcategory/deprecatedingredient strength(s)routedose formrldTEapprovedapplication
1ANDA076192_001RXRIBAVIRIN (200MG)ORALCAPSULEFalseAB2004-04-06RIBAVIRIN
2ANDA076203_001RXRIBAVIRIN (200MG)ORALCAPSULEFalseAB2004-04-06RIBASPHERE
3ANDA076277_001RXRIBAVIRIN (200MG)ORALCAPSULEFalseAB2004-10-04RIBAVIRIN
4ANDA077053_001RXRIBAVIRIN (200MG)ORALTABLETFalseAB2005-12-05RIBAVIRIN
5ANDA077094_001RXRIBAVIRIN (200MG)ORALTABLETFalseAB2005-12-05RIBAVIRIN
6ANDA077094_002RXRIBAVIRIN (400MG)ORALTABLETFalseAB2007-03-16RIBAVIRIN
7ANDA077094_003RXRIBAVIRIN (600MG)ORALTABLETFalseAB2007-03-16RIBAVIRIN
8ANDA077094_004RXRIBAVIRIN (500MG)ORALTABLETFalseAB2008-04-18RIBAVIRIN
9ANDA077224_001RXRIBAVIRIN (200MG)ORALCAPSULEFalseAB2005-10-28RIBAVIRIN
10ANDA077456_001RXRIBAVIRIN (200MG)ORALTABLETFalseAB2005-12-05RIBAVIRIN
11ANDA077456_002RXRIBAVIRIN (400MG)ORALTABLETFalseAB2005-12-05RIBAVIRIN
12ANDA077456_003RXRIBAVIRIN (600MG)ORALTABLETTrueAB2005-12-05RIBAVIRIN
13ANDA077743_001RXRIBAVIRIN (200MG)ORALTABLETFalseAB2006-10-03RIBAVIRIN
14ANDA079111_001RXRIBAVIRIN (200MG)ORALTABLETFalseAB2009-09-17RIBAVIRIN
15ANDA079117_001RXRIBAVIRIN (200MG)ORALCAPSULEFalseAB2009-09-17RIBAVARIN
16ANDA202546_001RXRIBAVIRIN (200MG)ORALTABLETFalseAB2014-08-12RIBAVIRIN
17ANDA202546_002RXRIBAVIRIN (400MG)ORALTABLETFalseAB2014-08-12RIBAVIRIN
18ANDA202546_003RXRIBAVIRIN (500MG)ORALTABLETFalseAB2014-08-12RIBAVIRIN
19ANDA202546_004RXRIBAVIRIN (600MG)ORALTABLETFalseAB2014-08-12RIBAVIRIN
20NDA020903_001discontinuedRIBAVIRIN (200MG)ORALCAPSULEFalse1998-06-03REBETOL
21NDA021511_001RXRIBAVIRIN (200MG)ORALTABLETFalseAB2002-12-03COPEGUS
22NDA021511_002discontinuedRIBAVIRIN (400MG)ORALTABLETFalse2005-06-21COPEGUS

patent(s)

#idexpiration dateapplication(s)in other drug docs
1p6172046 (view patent)2017-09-21NDA020903, NDA021546Ribavirin Oral Solution
Ribavirin Oral Capsule
2p6177074 (view patent)2016-11-01NDA020903, NDA021546Ribavirin Oral Solution
Ribavirin Oral Capsule
3p6461605 (view patent)2016-11-01NDA020903, NDA021546Ribavirin Oral Solution
Ribavirin Oral Capsule
4p6472373 (view patent)2017-09-21NDA020903, NDA021546Ribavirin Oral Solution
Ribavirin Oral Capsule
5p6524570 (view patent)2016-11-01NDA020903, NDA021546Ribavirin Oral Solution
Ribavirin Oral Capsule

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)
108992c51-8fe9-4d37-85cc-42ff337bda00 (view SPL)These highlights do not include all the information needed to use RIBAVIRIN TABLETS safely and effectively. See full prescribing information for RIBAVIRIN TABLETS. RIBAVIRIN tablets, for oral useInitial U.S. Approval: 2002prescriptionHuman PrescriptionZydus Pharmaceuticals (Usa) Inc.analysis, manufacture2015-10-0114683820046
212f3dec1-4299-4b93-8013-6fa6a963fd81 (view SPL)These highlights do not include all the information needed to use RIBASPHERE (ribavirin, USP) safely and effectively. See full prescribing information for RIBASPHERE (ribavirin, USP). RIBASPHERE (ribavirin, USP) Tablets for oral useInitial U.S. Approval: 2002prescriptionHuman PrescriptionKadmon Pharmaceuticals, LlcPACK, REPACK2015-02-208664350102, 664350103, 664350104, 664350105, 664350106, 664350107, 664350108
314d74b63-34ca-4897-bfdd-3e3952ab6088 (view SPL)RIBAVIRIN TABLETSprescriptionHuman PrescriptionState Of Florida Doh Central Pharmacyrepack2010-07-291538080782
43fc68fa7-3441-478f-a094-5afb7cdecd1f (view SPL)These highlights do not include all the information needed to use ribavirin tablets safely and effectively. See full prescribing information for ribavirin tablets. Ribavirin Tablets for oral useInitial U.S. Approval: 2002prescriptionHuman PrescriptionRichmond PharmaceuticalsREPACK2015-05-075547380950, 547380951, 547380952
5666e8b22-f519-460b-a774-88a621d56139 (view SPL)These highlights do not include all the information needed to use ribavirin safely and effectively. See full prescribing information for ribavirin. Initial U.S. Approval: 2002prescriptionHuman PrescriptionCadila Healthcare LimitedAnalysis, Manufacture2011-04-011658410046
67046ff4c-8a75-5fd4-d40f-ff0cc84eed5f (view SPL)These highlights do not include all the information needed to use Moderiba (ribavirin, USP) safely and effectively. See full prescribing information for Moderiba (ribavirin, USP).Moderiba (ribavirin, USP) Tablets for oral useInitial U.S. Approval: 2002prescriptionHuman PrescriptionAbbvie Inc.2015-10-2752000743197, 000743224, 000743239, 000743271, 000743282
7b600c2f8-f252-4f8f-92f5-922ac52bc341 (view SPL)These highlights do not include all the information needed to use ribavirin tablets safely and effectively. See full prescribing information for ribavirin tablets.RIBAVIRIN tablets for oral use Initial U.S. Approval: 2002prescriptionHuman PrescriptionTeva Pharmaceuticals Usa Inc2013-08-2811000937232
8bfab78e9-ca51-4ae7-87fa-924d6ca5608a (view SPL)prescriptionHuman PrescriptionRemedyrepack Inc.2011-11-301493490829
9cf7cf753-b35a-4f04-8dbe-f2cf8e229eec (view SPL)prescriptionHuman PrescriptionRemedyrepack Inc.2011-08-181493490486
10d370635f-5530-4d42-a019-d76b61639787 (view SPL)These highlights do not include all the information needed to use COPEGUS safely and effectively. See full prescribing information for COPEGUS. COPEGUS (ribavirin) Tablets, for oral use Initial U.S. Approval: 2002prescriptionHuman PrescriptionGenentech, Inc.ANALYSIS, API MANUFACTURE2015-08-2018000040086
11d58e820b-bfd2-4e66-9db4-03b526553c93 (view SPL)These highlights do not include all the information needed to use RIBAVIRIN TABLETS USP safely and effectively. See full prescribing information for RIBAVIRIN TABLETS USP. RIBAVIRIN TABLETS USP, for oral useInitial U.S. Approval: 2002prescriptionHuman PrescriptionSandoz Inc2015-08-1413007815177
12eee304d0-c2ea-44f4-97d9-92a414d31b6c (view SPL)These highlights do not include all the information needed to use RIBAVIRIN TABLETS safely and effectively. See full prescribing information for RIBAVIRIN TABLETS. RIBAVIRIN tablets, USP for oral useInitial U.S. Approval: 2002prescriptionHuman PrescriptionAurobindo Pharma LimitedANALYSIS, API MANUFACTURE, MANUFACTURE2015-10-0312658620207

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