Ribavirin Oral Capsule

Brand(s)
Rebetol, Ribasphere
Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Aurobindo Pharma Limited (2015-07-02)
Oldest Current Product
1998-06-03
License(s)
NDA, ANDA
RxNORM
ORAL CAPSULE\RIBAVIRIN
FDAOB
ORAL\CAPSULE\RIBAVIRIN
SPL Active
ORAL\CAPSULE\RIBAVIRIN
SPL Moiety
ORAL\CAPSULE\RIBAVIRIN

product(s) by strength(s)

ribavirin 200 mg oral capsule

generic product(s)(s)

#idbrandcategorylabelerfirst marketedlast marketedactive ingredient(s)routedose formapplicationspl
1000937227ANDATeva Pharmaceuticals Usa Inc2004-10-042015-11-30RIBAVIRINORALCAPSULEANDA076277f59980f4-8103-45ea-9643-13a133e14415
2007812043ANDASandoz Inc2004-04-06RIBAVIRINORALCAPSULEANDA076192dc637c8f-9669-4bc5-8787-1fd5abaa588e
3547380953ANDARichmond Pharmaceuticals2007-11-01RIBAVIRINORALCAPSULEANDA076203b1397a52-d99f-44f0-8649-8ceb8e7b9b85
4658410260ANDACadila Healthcare Limited2006-01-25RIBAVIRINORALCAPSULEANDA077224b97cd49c-9e19-4a35-987c-06e62bb25b6b
5658620290ANDAAurobindo Pharma Limited2009-09-17RIBAVIRINORALCAPSULEANDA07911735f99f76-f2ef-4a81-91ff-285419664be3
6664350101RibasphereANDAKadmon Pharmaceuticals, Llc2004-04-07RIBAVIRINORALCAPSULEANDA0762037dfd3fdd-efa4-4239-8cd7-ddf2de682328
7683820260ANDAZydus Pharmaceuticals (Usa) Inc.2006-01-25RIBAVIRINORALCAPSULEANDA07722427c184e4-e8ac-4ec5-882f-cf4f27030e4c

invalid application product(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1000851194RebetolNDAMerck Sharp & Dohme Corp.1998-06-03RIBAVIRINORALCAPSULENDA02090304d2b6f4-bd9b-4871-9527-92c81aa2d4d0
2000851351RebetolNDAMerck Sharp & Dohme Corp.1998-06-03RIBAVIRINORALCAPSULENDA02090304d2b6f4-bd9b-4871-9527-92c81aa2d4d0
3000851385RebetolNDAMerck Sharp & Dohme Corp.1998-06-03RIBAVIRINORALCAPSULENDA02090304d2b6f4-bd9b-4871-9527-92c81aa2d4d0

relabeler product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1422910718ANDAAvkare, Inc.2014-01-17RIBAVIRINORALCAPSULE000937227ANDA07627719d7a079-4b59-de14-cd8e-3a6597caac99
2538080781ANDAState Of Florida Doh Central Pharmacy2009-07-01RIBAVIRINORALCAPSULE007812043ANDA0761923b8b0c65-e466-4662-9e85-5a253d31ebe8
3680840179ANDAAmerican Health Packaging2006-11-30RIBAVIRINORALCAPSULE683820260ANDA0772249ed7adc9-bd0c-41af-b34c-43d15a7799d1

application(s)

#idtitledeprecatedapplicantapprovedpatentapproved drugin other drug docs
1ANDA076192RIBAVIRINSANDOZ INC2004-04-06ANDA076192_001Ribavirin Oral Tablet
2ANDA076203RIBASPHERETHREE RIVERS PHARMACEUTICALS LLC2004-04-06ANDA076203_001Ribavirin Oral Tablet
3ANDA076277RIBAVIRINTEVA PHARMACEUTICALS USA INC2004-10-04ANDA076277_001Ribavirin Oral Tablet
4ANDA077224RIBAVIRINZYDUS PHARMACEUTICALS USA INC2005-10-28ANDA077224_001Ribavirin Oral Tablet
5ANDA079117RIBAVARINAUROBINDO PHARMA LTD2009-09-17ANDA079117_001Ribavirin Oral Tablet
6NDA020903REBETOLTrueMERCK 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 Tablet

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
4ANDA077224_001RXRIBAVIRIN (200MG)ORALCAPSULEFalseAB2005-10-28RIBAVIRIN
5ANDA079117_001RXRIBAVIRIN (200MG)ORALCAPSULEFalseAB2009-09-17RIBAVARIN
6NDA020903_001discontinuedRIBAVIRIN (200MG)ORALCAPSULEFalse1998-06-03REBETOL

patent(s)

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

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)in other drug docs
104d2b6f4-bd9b-4871-9527-92c81aa2d4d0 (view SPL)These highlights do not include all the information needed to use REBETOL safely and effectively. See full prescribing information for REBETOL.REBETOL (ribavirin USP) capsules, for oral use REBETOL (ribavirin USP) oral solutionInitial U.S. Approval: 1998prescriptionHuman PrescriptionMerck Sharp & Dohme Corp.API MANUFACTURE, LABEL, MANUFACTURE, PACK2015-05-2121000851194, 000851351, 000851385, 000851318Ribavirin Oral Solution
219d7a079-4b59-de14-cd8e-3a6597caac99 (view SPL)These highlights do not include all the information needed to use ribavirin capsules safely and effectively. See full prescribing information for ribavirin capsules. RIBAVIRIN capsules for oral use Initial U.S. Approval: 1998prescriptionHuman PrescriptionAvkare, Inc.2015-02-202422910718
327c184e4-e8ac-4ec5-882f-cf4f27030e4c (view SPL)These highlights do not include all the information needed to use ribavirin capsules, USP safely and effectively. See full prescribing information for ribavirin capsules, USP. RIBAVIRIN capsules USP, for oral useInitial U.S. Approval: 1998prescriptionHuman PrescriptionZydus Pharmaceuticals (Usa) Inc.analysis, manufacture2015-06-016683820260
435f99f76-f2ef-4a81-91ff-285419664be3 (view SPL)These highlights do not include all the information needed to use ribavirin capsules safely and effectively.See full prescribing information for ribavirin capsules. RIBAVIRIN capsules USP, for oral useInitial U.S. Approval: 1998prescriptionHuman PrescriptionAurobindo Pharma LimitedANALYSIS, API MANUFACTURE, MANUFACTURE2015-07-0210658620290
53b8b0c65-e466-4662-9e85-5a253d31ebe8 (view SPL)Ribavirin Capsules200 mgprescriptionHuman PrescriptionState Of Florida Doh Central Pharmacyrepack2010-06-081538080781
67dfd3fdd-efa4-4239-8cd7-ddf2de682328 (view SPL)These highlights do not include all the information needed to use RIBASPHERE (ribavirin capsules USP) safely and effectively. See full prescribing information for RIBASPHERE.RIBASPHERE (ribavirin capsules USP) 200 mg, for oral useInitial U.S. Approval: 1998prescriptionHuman PrescriptionKadmon Pharmaceuticals, LlcMANUFACTURE2015-10-138664350101
79ed7adc9-bd0c-41af-b34c-43d15a7799d1 (view SPL)These highlights do not include all the information needed to use ribavirin capsules safely and effectively. See full prescribing information for ribavirin capsules. RIBAVIRIN capsules USP, for oral useInitial U.S. Approval: 1998prescriptionHuman PrescriptionAmerican Health PackagingREPACK2015-10-093680840179
8b1397a52-d99f-44f0-8649-8ceb8e7b9b85 (view SPL)These highlights do not include all the information needed to use ribavirin capsules safely and effectively. See full prescribing information for ribavirin capsules.Ribavirin capsules 200 mgInitial U.S. Approval: 1998prescriptionHuman PrescriptionRichmond PharmaceuticalsMANUFACTURE2014-12-194547380953
9b97cd49c-9e19-4a35-987c-06e62bb25b6b (view SPL)These highlights do not include all the information needed to use ribavirin capsules safely and effectively. See full prescribing information for ribavirin capsules. Initial U.S. Approval: 1998prescriptionHuman PrescriptionCadila Healthcare LimitedAnalysis, Manufacture2011-04-011658410260
10dc637c8f-9669-4bc5-8787-1fd5abaa588e (view SPL)These highlights do not include all the information needed to use RIBAVIRIN CAPSULES USP safely and effectively. See full prescribing information for RIBAVIRIN CAPSULES USP.Ribavirin Capsules USP for oral useInitial U.S. Approval: 1998prescriptionHuman PrescriptionSandoz Inc2015-05-2816007812043
11f59980f4-8103-45ea-9643-13a133e14415 (view SPL)These highlights do not include all the information needed to use ribavirin capsules safely and effectively. See full prescribing information for ribavirin capsules. RIBAVIRIN capsules, for oral use Initial U.S. Approval: 1998prescriptionHuman PrescriptionTeva Pharmaceuticals Usa Inc2014-09-0511000937227

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