Orange Book product · Generic (ANDA)
ARGATROBAN
ARGATROBAN
At a glance
Sep 21, 2016
Approved
Generic (ANDA)
Application
AP
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Sep 21, 2016
9 yr 11 mo ago
Today
Pharmaceutical detail
Active ingredient
ARGATROBAN
Strength
250MG/2.5ML (100MG/ML)
Dosage form
INJECTABLE
Route
INJECTION
TE code
AP
Application
ANDA 204120
Product number
001
Marketing status
RX
Reference listed drug (RLD)
No
Reference standard (RS)
Yes
Active-ingredient family
View full familyGeneric (ANDA) of ARGATROBAN
- 2021ARGATROBAN IN SODIUM CHLORIDEBrand (NDA)
NDA 212035 · ACCORD HLTHCARE
- 2018ARGATROBAN IN SODIUM CHLORIDEBrand (NDA)
NDA 209552 · EUGIA PHARMA SPECLTS
- 2016ARGATROBANBrand (NDA)
NDA 203049 · HIKMA PHARM CO LTD
- 2015ARGATROBANBrand (NDA)
NDA 201811 · FRESENIUS KABI USA
- 2014ARGATROBAN IN 0.9% SODIUM CHLORIDEBrand (NDA)
NDA 206769 · TEVA PHARMS USA
- 2011ARGATROBAN IN SODIUM CHLORIDEBrand (NDA)
NDA 022434 · CIPLA
- 2011ARGATROBAN IN SODIUM CHLORIDEBrand (NDA)
NDA 022485 · PLANO PHARMS
- 2011ARGATROBAN IN DEXTROSEBrand (NDA)
NDA 201743 · SANDOZ
- 2000ARGATROBANBrand (NDA)
NDA 020883 · SANDOZ
- 2023ARGATROBANGeneric (ANDA)
ANDA 217848 · GLAND
- 2021ARGATROBANGeneric (ANDA)
ANDA 214235 · CAPLIN
- 2018ARGATROBANGeneric (ANDA)
ANDA 206698 · AMNEAL PHARMS CO
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.
