Orange Book product · Brand (NDA)
SYMLIN
PRAMLINTIDE ACETATE
Brand (NDA)NDA 021332DISCN ASTRAZENECA AB
At a glance
Sep 25, 2007
Approved
Brand (NDA)
Application
Not listed
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Sep 25, 2007
19 yr ago
Today
Pharmaceutical detail
Active ingredient
PRAMLINTIDE ACETATE
Strength
EQ 2.7MG BASE/2.7ML (EQ 1MG BASE/ML)
Dosage form
INJECTABLE
Route
SUBCUTANEOUS
TE code
Not listed
Application
NDA 021332
Product number
003
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.
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.
