Orange Book product · Brand (NDA)
REBETOL
RIBAVIRIN
At a glance
Jul 25, 2001
Approved
Brand (NDA)
Application
Not listed
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Jul 25, 2001
25 yr 3 mo ago
Today
Pharmaceutical detail
Active ingredient
RIBAVIRIN
Strength
200MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Dosage form
CAPSULE
Route
ORAL
TE code
Not listed
Application
NDA 020903
Product number
002
Marketing status
DISCN
Reference listed drug (RLD)
Yes
Reference standard (RS)
No
Active-ingredient family
View full familyThis is a reference-listed drug (RLD) — the basis for generic (ANDA) applications. Other products sharing this ingredient are listed below.
- 2003REBETOLBrand (NDA)
NDA 021546 · SCHERING
- 2002COPEGUSBrand (NDA)
NDA 021511 · ROCHE
- 1985VIRAZOLEBrand (NDA)
NDA 018859 · BAUSCH
- 2016RIBAVIRINGeneric (ANDA)
ANDA 207366 · NAVINTA LLC
- 2014RIBAVIRINGeneric (ANDA)
ANDA 202546 · BEXIMCO PHARMS USA
- 2009RIBAVIRINGeneric (ANDA)
ANDA 079117 · AUROBINDO PHARMA
- 2009RIBAVIRINGeneric (ANDA)
ANDA 079111 · AUROBINDO PHARMA
- 2006RIBAVIRINGeneric (ANDA)
ANDA 077743 · SANDOZ
- 2005RIBAVIRINGeneric (ANDA)
ANDA 077456 · CHARTWELL RX
- 2005RIBAVIRINGeneric (ANDA)
ANDA 077053 · HERITAGE PHARMA AVET
- 2005RIBAVIRINGeneric (ANDA)
ANDA 077094 · ZYDUS PHARMS USA
- 2005RIBAVIRINGeneric (ANDA)
ANDA 077224 · ZYDUS PHARMS USA
Listed patents
No patents are listed against this product in the Orange Book. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.
