01 2AMNEAL
02 2AMYLIN
03 5ASTRAZENECA AB
01 2FOR SUSPENSION, EXTENDED RELEASE;SUBCUTANEOUS
02 2INJECTABLE; SUBCUTANEOUS
03 4INJECTABLE;SUBCUTANEOUS
04 1SUSPENSION, EXTENDED RELEASE;SUBCUTANEOUS
01 2DISCN
02 3RX
03 4Blank
01 1BYDUREON
02 1BYDUREON BCISE
03 1BYDUREON PEN
04 4BYETTA
05 2EXENATIDE SYNTHETIC
01 5Yes
02 4Blank
RLD :
TE Code :
Brand Name : EXENATIDE SYNTHETIC
Dosage Form : INJECTABLE;SUBCUTANEOUS
Dosage Strength : 300MCG/1.2ML (250MCG/ML)
Approval Date :
Application Number : 206697
RX/OTC/DISCN :
RLD :
TE Code :
RLD :
TE Code :
Brand Name : EXENATIDE SYNTHETIC
Dosage Form : INJECTABLE;SUBCUTANEOUS
Dosage Strength : 600MCG/2.4ML (250MCG/ML)
Approval Date :
Application Number : 206697
RX/OTC/DISCN :
RLD :
TE Code :
RLD : Yes
TE Code :
Brand Name : BYETTA
Dosage Form : INJECTABLE;SUBCUTANEOUS
Dosage Strength : 300MCG/1.2ML (250MCG/ML)
Approval Date : 2005-04-28
Application Number : 21773
RX/OTC/DISCN : RX
RLD : Yes
TE Code :
RLD : Yes
TE Code :
Brand Name : BYETTA
Dosage Form : INJECTABLE;SUBCUTANEOUS
Dosage Strength : 600MCG/2.4ML (250MCG/ML)
Approval Date : 2005-04-28
Application Number : 21773
RX/OTC/DISCN : RX
RLD : Yes
TE Code :
RLD :
TE Code :
Brand Name : BYETTA
Dosage Form : INJECTABLE; SUBCUTANEOUS
Dosage Strength : 300UGM/1.2ML (250UGM/ML)
Approval Date :
Application Number : 21919
RX/OTC/DISCN :
RLD :
TE Code :
RLD :
TE Code :
Brand Name : BYETTA
Dosage Form : INJECTABLE; SUBCUTANEOUS
Dosage Strength : 600UGM/2.4ML (250UGM/ML)
Approval Date :
Application Number : 21919
RX/OTC/DISCN :
RLD :
TE Code :
RLD : Yes
TE Code :
Brand Name : BYDUREON
Dosage Form : FOR SUSPENSION, EXTENDED RELEASE;SUBCUTANEOUS
Dosage Strength : 2MG/VIAL
Approval Date : 2012-01-27
Application Number : 22200
RX/OTC/DISCN : DISCN
RLD : Yes
TE Code :
RLD : Yes
TE Code :
Brand Name : BYDUREON PEN
Dosage Form : FOR SUSPENSION, EXTENDED RELEASE;SUBCUTANEOUS
Dosage Strength : 2MG
Approval Date : 2014-02-28
Application Number : 22200
RX/OTC/DISCN : DISCN
RLD : Yes
TE Code :
RLD : Yes
TE Code :
Brand Name : BYDUREON BCISE
Dosage Form : SUSPENSION, EXTENDED RELEASE;SUBCUTANEOUS
Dosage Strength : 2MG/0.85ML (2MG/0.85ML)
Approval Date : 2017-10-20
Application Number : 209210
RX/OTC/DISCN : RX
RLD : Yes
TE Code :
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