Orange Book product · Brand (NDA)
ARGATROBAN IN SODIUM CHLORIDE
ARGATROBAN
At a glance
Jun 07, 2021
Approved
Brand (NDA)
Application
Not listed
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Jun 07, 2021
5 yr 1 mo ago
Today
Pharmaceutical detail
Active ingredient
ARGATROBAN
Strength
50MG/50ML (1MG/ML)
Dosage form
SOLUTION
Route
INTRAVENOUS
TE code
Not listed
Application
NDA 212035
Product number
001
Marketing status
RX
Reference listed drug (RLD)
Yes
Reference standard (RS)
Yes
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.
- 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
- 2017ARGATROBAN IN SODIUM CHLORIDEGeneric (ANDA)
ANDA 205570 · GLAND
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.
