01 1ACTAVIS LABS FL
02 2CUBIST PHARMS LLC
01 1FOR SUSPENSION;ORAL
02 2TABLET;ORAL
01 1DISCN
02 2RX
01 2DIFICID
02 1FIDAXOMICIN
01 1No
02 2Yes
RLD : No
TE Code :
Brand Name : FIDAXOMICIN
Dosage Form : TABLET;ORAL
Dosage Strength : 200MG
Approval Date : 2024-01-16
Application Number : 208443
RX/OTC/DISCN : DISCN
RLD : No
TE Code :
RLD : Yes
TE Code :
Brand Name : DIFICID
Dosage Form : TABLET;ORAL
Dosage Strength : 200MG
Approval Date : 2011-05-27
Application Number : 201699
RX/OTC/DISCN : RX
RLD : Yes
TE Code :
RLD : Yes
TE Code :
Brand Name : DIFICID
Dosage Form : FOR SUSPENSION;ORAL
Dosage Strength : 40MG/ML
Approval Date : 2020-01-24
Application Number : 213138
RX/OTC/DISCN : RX
RLD : Yes
TE Code :
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