Orange Book product · Generic (ANDA)
LINACLOTIDE
LINACLOTIDE
Generic (ANDA)ANDA 209564DISCN MYLAN
At a glance
Feb 09, 2021
Approved
Generic (ANDA)
Application
Not listed
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Feb 09, 2021
5 yr 5 mo ago
Today
Pharmaceutical detail
Active ingredient
LINACLOTIDE
Strength
145MCG
Dosage form
CAPSULE
Route
ORAL
TE code
Not listed
Application
ANDA 209564
Product number
001
Marketing status
DISCN
Reference listed drug (RLD)
No
Reference standard (RS)
No
Active-ingredient family
View full familyGeneric (ANDA) of LINACLOTIDE
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.
