Orange Book product · Brand (NDA)
COPEGUS
RIBAVIRIN
At a glance
Dec 03, 2002
Approved
Brand (NDA)
Application
Not listed
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Dec 03, 2002
23 yr 11 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200MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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
TABLET
Route
ORAL
TE code
Not listed
Application
NDA 021511
Product number
001
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
- 1998REBETOLBrand (NDA)
NDA 020903 · MERCK SHARP DOHME
- 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.
