Orange Book product · Generic (ANDA)
MISOPROSTOL
MISOPROSTOL
Generic (ANDA)ANDA 091667DISCN NOVEL LABS INC
At a glance
Jul 25, 2012
Approved
Generic (ANDA)
Application
Not listed
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Jul 25, 2012
14 yr 1 mo ago
Today
Pharmaceutical detail
Active ingredient
MISOPROSTOL
Strength
0.1MG
Dosage form
TABLET
Route
ORAL
TE code
Not listed
Application
ANDA 091667
Product number
001
Marketing status
DISCN
Reference listed drug (RLD)
No
Reference standard (RS)
No
Active-ingredient family
View full familyGeneric (ANDA) of MISOPROSTOL
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.
