Orange Book product · Brand (NDA)
EDEX
ALPROSTADIL
At a glance
Jun 12, 1997
Approved
Brand (NDA)
Application
AP
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Jun 12, 1997
29 yr 5 mo ago
Today
Pharmaceutical detail
Active ingredient
ALPROSTADIL
Strength
0.02MG/VIAL
Dosage form
INJECTABLE
Route
INJECTION
TE code
AP
Application
NDA 020649
Product number
003
Marketing status
RX
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.
- 2002CAVERJECT IMPULSEBrand (NDA)
NDA 021212 · PFIZER
- 1997CAVERJECTBrand (NDA)
NDA 020755 · PFIZER
- 1996MUSEBrand (NDA)
NDA 020700 · VIATRIS
- 1996CAVERJECTBrand (NDA)
NDA 020379 · PFIZER
- —PROSTIN VR PEDIATRICBrand (NDA)
NDA 018484 · PFIZER
- 1999ALPROSTADILGeneric (ANDA)
ANDA 075196 · MEITHEAL
- 1998ALPROSTADILGeneric (ANDA)
ANDA 074815 · HIKMA
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.
