01 1ACCORD HLTHCARE
02 1AMNEAL PHARMS CO
03 1BAXTER HLTHCARE CORP
04 1CAPLIN
05 1CIPLA
06 1ENDO OPERATIONS
07 1EUGIA PHARMA SPECLTS
08 1FRESENIUS KABI USA
09 2GLAND PHARMA LTD
10 2HIKMA PHARM CO LTD
11 1HOSPIRA
12 1MYLAN INSTITUTIONAL
13 1PLIVA HRVATSKA DOO
14 3SANDOZ
15 1TEVA PHARMS USA
01 2INJECTABLE; INJECTION
02 10INJECTABLE;INJECTION
03 4INJECTABLE;INTRAVENOUS
04 3SOLUTION;INTRAVENOUS
01 4DISCN
02 13RX
03 2Blank
01 12ARGATROBAN
02 1ARGATROBAN IN 0.9% SODIUM CHLORIDE
03 1ARGATROBAN IN DEXTROSE
04 5ARGATROBAN IN SODIUM CHLORIDE
01 11No
02 6Yes
03 2Blank
RLD :
TE Code :
Brand Name : ARGATROBAN
Dosage Form : INJECTABLE; INJECTION
Dosage Strength : 250MG/250ML
Approval Date :
Application Number : 22359
RX/OTC/DISCN :
RLD :
TE Code :
RLD : Yes
TE Code :
Brand Name : ARGATROBAN IN SODIUM CHLORIDE
Dosage Form : INJECTABLE;INTRAVENOUS
Dosage Strength : 50MG/50ML (1MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date : 2011-06-29
Application Number : 22434
RX/OTC/DISCN : DISCN
RLD : Yes
TE Code :
RLD : No
TE Code : AP
Brand Name : ARGATROBAN
Dosage Form : INJECTABLE;INJECTION
Dosage Strength : 250MG/2.5ML (100MG/ML)
Approval Date : 2015-03-23
Application Number : 201811
RX/OTC/DISCN : RX
RLD : No
TE Code : AP
RLD : Yes
TE Code : AP
Brand Name : ARGATROBAN
Dosage Form : INJECTABLE;INJECTION
Dosage Strength : 250MG/2.5ML (100MG/ML)
Approval Date : 2012-01-05
Application Number : 203049
RX/OTC/DISCN : RX
RLD : Yes
TE Code : AP
RLD :
TE Code :
Brand Name : ARGATROBAN
Dosage Form : INJECTABLE; INJECTION
Dosage Strength : 100MG
Approval Date :
Application Number : 79238
RX/OTC/DISCN :
RLD :
TE Code :
RLD : Yes
TE Code :
Brand Name : ARGATROBAN
Dosage Form : INJECTABLE;INJECTION
Dosage Strength : 250MG/2.5ML (100MG/ML)
Approval Date : 2000-06-30
Application Number : 20883
RX/OTC/DISCN : DISCN
RLD : Yes
TE Code :
RLD : Yes
TE Code : AP
Brand Name : ARGATROBAN IN SODIUM CHLORIDE
Dosage Form : INJECTABLE;INTRAVENOUS
Dosage Strength : 125MG/125ML (1MG/ML)
Approval Date : 2011-05-09
Application Number : 22485
RX/OTC/DISCN : RX
RLD : Yes
TE Code : AP
RLD : No
TE Code :
Brand Name : ARGATROBAN IN DEXTROSE
Dosage Form : SOLUTION;INTRAVENOUS
Dosage Strength : 125MG/125ML (1MG/ML)
Approval Date : 2011-05-09
Application Number : 201743
RX/OTC/DISCN : DISCN
RLD : No
TE Code :
RLD : No
TE Code : AP
Brand Name : ARGATROBAN
Dosage Form : INJECTABLE;INJECTION
Dosage Strength : 250MG/2.5ML (100MG/ML)
Approval Date : 2014-06-30
Application Number : 202626
RX/OTC/DISCN : RX
RLD : No
TE Code : AP
Brand Name : ARGATROBAN
Dosage Form : INJECTABLE;INJECTION
Dosage Strength : 250MG/2.5ML (100MG/ML)
Approval Date : 2014-06-30
Application Number : 91665
RX/OTC/DISCN : RX
RLD : No
TE Code : AP
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