Orange Book product · Brand (NDA)
BLENOXANE
BLEOMYCIN SULFATE
At a glance
Sep 07, 1995
Approved
Brand (NDA)
Application
Not listed
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Sep 07, 1995
31 yr 3 mo ago
Today
Pharmaceutical detail
Active ingredient
BLEOMYCIN SULFATE
Strength
EQ 30 UNITS BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Dosage form
INJECTABLE
Route
INJECTION
TE code
Not listed
Application
NDA 050443
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.
- 2019BLEOMYCIN SULFATEGeneric (ANDA)
ANDA 209439 · CIPLA
- 2018BLEOMYCIN SULFATEGeneric (ANDA)
ANDA 205030 · MEITHEAL
- 2008BLEOMYCIN SULFATEGeneric (ANDA)
ANDA 065185 · FRESENIUS KABI USA
- 2007BLEOMYCIN SULFATEGeneric (ANDA)
ANDA 065201 · PHARMACHEMIE BV
- 2001BLEOMYCIN SULFATEGeneric (ANDA)
ANDA 065042 · HIKMA
- 2000BLEOMYCIN SULFATEGeneric (ANDA)
ANDA 065033 · TEVA PHARMS USA
- 2000BLEOMYCIN SULFATEGeneric (ANDA)
ANDA 065031 · HOSPIRA
- 1996BLEOMYCIN SULFATEGeneric (ANDA)
ANDA 064084 · TEVA PARENTERAL
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.
