01 1ALVIMOPAN
02 1CEFTOLOZANE SULFATE; TAZOBACTAM SODIUM
03 3DAPTOMYCIN
04 2FIDAXOMICIN
05 2TEDIZOLID PHOSPHATE
01 1CAPSULE;ORAL
02 1FOR SUSPENSION;ORAL
03 5POWDER;INTRAVENOUS
04 2TABLET;ORAL
01 112MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
02 2200MG
03 1200MG/VIAL
04 1250MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
05 140MG/ML
06 2500MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
07 1EQ 1GM BASE/VIAL;EQ 0.5GM BASE/VIAL
01 4DISCN
02 5RX
RLD : Yes
TE Code :
Dosage Form : CAPSULE; ORAL
Proprietary Name : ENTEREG
Dosage Strength : 12MG **Federal Register ...
Approval Date : 2008-05-20
Application Number : 21775
RX/OTC/DISCN : DISCN
RLD : Yes
TE Code :
RLD : Yes
TE Code :
CEFTOLOZANE SULFATE; TAZOBACTAM SODIUM
Dosage Form : POWDER; INTRAVENOUS
Proprietary Name : ZERBAXA
Dosage Strength : EQ 1GM BASE/VIAL;EQ 0.5G...
Approval Date : 2014-12-19
Application Number : 206829
RX/OTC/DISCN : RX
RLD : Yes
TE Code :
RLD : No
TE Code :
Dosage Form : POWDER; INTRAVENOUS
Proprietary Name : CUBICIN
Dosage Strength : 250MG/VIAL **Federal Reg...
Approval Date : 2003-09-12
Application Number : 21572
RX/OTC/DISCN : DISCN
RLD : No
TE Code :
RLD : Yes
TE Code :
Dosage Form : POWDER; INTRAVENOUS
Proprietary Name : CUBICIN
Dosage Strength : 500MG/VIAL **Federal Reg...
Approval Date : 2003-09-12
Application Number : 21572
RX/OTC/DISCN : DISCN
RLD : Yes
TE Code :
RLD : Yes
TE Code :
Dosage Form : POWDER; INTRAVENOUS
Proprietary Name : CUBICIN RF
Dosage Strength : 500MG/VIAL **Federal Reg...
Approval Date : 2016-07-06
Application Number : 21572
RX/OTC/DISCN : DISCN
RLD : Yes
TE Code :
RLD : Yes
TE Code :
Dosage Form : TABLET; ORAL
Proprietary Name : DIFICID
Dosage Strength : 200MG
Approval Date : 2011-05-27
Application Number : 201699
RX/OTC/DISCN : RX
RLD : Yes
TE Code :
RLD : Yes
TE Code :
Dosage Form : FOR SUSPENSION; ORAL
Proprietary Name : DIFICID
Dosage Strength : 40MG/ML
Approval Date : 2020-01-24
Application Number : 213138
RX/OTC/DISCN : RX
RLD : Yes
TE Code :
RLD : Yes
TE Code :
Dosage Form : TABLET; ORAL
Proprietary Name : SIVEXTRO
Dosage Strength : 200MG
Approval Date : 2014-06-20
Application Number : 205435
RX/OTC/DISCN : RX
RLD : Yes
TE Code :
RLD : Yes
TE Code :
Dosage Form : POWDER; INTRAVENOUS
Proprietary Name : SIVEXTRO
Dosage Strength : 200MG/VIAL
Approval Date : 2014-06-20
Application Number : 205436
RX/OTC/DISCN : RX
RLD : Yes
TE Code :
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