Ribavirin Oral Solution

Brand(s)
Rebetol
Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Merck Sharp & Dohme Corp. (2015-05-21)
Oldest Current Product
2003-07-29
License(s)
NDA
RxNORM
ORAL SOLUTION\RIBAVIRIN
FDAOB
ORAL\SOLUTION\RIBAVIRIN
SPL Active
ORAL\LIQUID\RIBAVIRIN
SPL Moiety
ORAL\LIQUID\RIBAVIRIN

product(s) by strength(s)

ribavirin 40 mg/ml oral solution

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1000851318RebetolNDAMerck Sharp & Dohme Corp.2003-07-29RIBAVIRINORALLIQUIDNDA02154604d2b6f4-bd9b-4871-9527-92c81aa2d4d0

application(s)

#idtitleapplicantapprovedpatentapproved drug
1NDA021546REBETOLSCHERING CORP2003-07-29p6472373, METHOD OF USING RIBAVIRIN IN COMBINATION WITH INTRON A (INTERFERON ALPHA-2 B RECOMBINANT) INJECTION TO TREAT PATIENTS WITH CHRONIC HEPATITIS C
p6790837, SUBSTANCE
p6177074, METHOD OF USING RIBAVIRIN IN COMBINATION WITH PEGYLATED INTERFERON ALPHA-2B TO TREAT PATIENTS WITH CHRONIC HEPATITIS C
p6461605, METHOD OF USING RIBAVIRIN IN COMBINATION WITH PEGYLATED INTERFERON ALPHA-2B TO TREAT PATIENTS WITH CHRONIC HEPATITIS C/ METHOD OF USING RIBAVIRIN IN COMBINATION WITH INTRON A (INTERFERON ALPHA-2 B RECOMBINANT) INJECTION TO TREAT PATIENTS WITH CHRONIC HEPATITIS C
p6172046, METHOD OF USING RIBAVIRIN IN COMBINATION WITH INTERFERON ALPHA-2B(PEGYLATED AND NONPEGYLATED) TO TREAT PATIENTS WITH CHRONIC HEPATITIS C/ METHOD OF USING RIBAVIRIN IN COMBINATION WITH INTRON A (INTERFERON ALPHA-2 B RECOMBINANT) INJECTION TO TREAT PATIENTS WITH CHRONIC HEPATITIS C
p6524570, METHOD OF USING RIBAVIRIN IN COMBINATION WITH PEGYLATED INTERFERON ALPHA-2B TO TREAT PATIENTS WITH CHRONIC HEPATITIS C
NDA021546_001

application drug(s)

#idcategory/deprecatedingredient strength(s)routedose formrldapprovedapplication
1NDA021546_001RXRIBAVIRIN (40MG/ML)ORALSOLUTIONTrue2003-07-29REBETOL

patent(s)

#idexpiration dateapplication(s)in other drug docs
1p6172046 (view patent)2017-09-21NDA021546, NDA020903Ribavirin Oral Tablet
Ribavirin Oral Capsule
2p6177074 (view patent)2016-11-01NDA021546, NDA020903Ribavirin Oral Tablet
Ribavirin Oral Capsule
3p6461605 (view patent)2016-11-01NDA021546, NDA020903Ribavirin Oral Tablet
Ribavirin Oral Capsule
4p6472373 (view patent)2017-09-21NDA021546, NDA020903Ribavirin Oral Tablet
Ribavirin Oral Capsule
5p6524570 (view patent)2016-11-01NDA021546, NDA020903Ribavirin Oral Tablet
Ribavirin Oral Capsule
6p6790837 (view patent)2023-04-05NDA021546

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, PACK2015-05-2121000851318, 000851194, 000851351, 000851385Ribavirin Oral Capsule

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