Orange Book product · Generic (ANDA)
PROTAMINE SULFATE
PROTAMINE SULFATE
Generic (ANDA)ANDA 089454RX FRESENIUS KABI USA
At a glance
Apr 07, 1987
Approved
Generic (ANDA)
Application
Not listed
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Apr 07, 1987
39 yr 9 mo ago
Today
Pharmaceutical detail
Active ingredient
PROTAMINE SULFATE
Strength
50MG/5ML (10MG/ML)
Dosage form
SOLUTION
Route
INTRAVENOUS
TE code
Not listed
Application
ANDA 089454
Product number
001
Marketing status
RX
Reference listed drug (RLD)
No
Reference standard (RS)
Yes
Active-ingredient family
View full familyGeneric (ANDA) of PROTAMINE SULFATE
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.
