Orange Book product · Brand (NDA)
FRAGMIN
DALTEPARIN SODIUM
Brand (NDA)NDA 020287RX PFIZER
At a glance
Mar 15, 2022
Approved
Brand (NDA)
Application
Not listed
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Mar 15, 2022
4 yr 4 mo ago
Today
Pharmaceutical detail
Active ingredient
DALTEPARIN SODIUM
Strength
10,000IU/4ML (2,500IU/ML)
Dosage form
INJECTABLE
Route
SUBCUTANEOUS
TE code
Not listed
Application
NDA 020287
Product number
012
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.
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.
