Orange Book product · Brand (NDA)
ARGATROBAN IN SODIUM CHLORIDE
ARGATROBAN
At a glance
Jun 29, 2011
Approved
Brand (NDA)
Application
Not listed
TE code
2
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Jun 29, 2011
15 yr 2 mo ago
Today
Patent 7589106 expires
Listed drug product patent expiration.
Sep 26, 2027
in 1 yr 3 mo
Patent 7687516 expires
Listed drug product patent expiration.
Sep 26, 2027
in 1 yr 3 mo
Pharmaceutical detail
Active ingredient
ARGATROBAN
Strength
50MG/50ML (1MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Dosage form
INJECTABLE
Route
INTRAVENOUS
TE code
Not listed
Application
NDA 022434
Product number
001
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.
- 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 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 (2)
| Patent | Expires | In | Type |
|---|---|---|---|
| 7589106 | Sep 26, 2027 | in 1 yr 3 mo | ProductU-1163 |
| 7687516 | Sep 26, 2027 | in 1 yr 3 mo | ProductU-1164 |
