01 4BACLOFEN
02 1BIVALIRUDIN
03 2BORTEZOMIB
04 3LEVOTHYROXINE SODIUM
05 1SINCALIDE
06 2SODIUM BENZOATE; SODIUM PHENYLACETATE
01 4INJECTABLE;INTRATHECAL
02 4POWDER;INTRAVENOUS
03 5SOLUTION;INTRAVENOUS
01 10.005MG/VIAL
02 10.05MG/ML
03 10.5MG/ML
04 110%;10% (2GM/20ML;2GM/20ML)
05 110%;10% (5GM/50ML;5GM/50ML)
06 1100MCG/VIAL
07 11MG/ML
08 1200MCG/VIAL
09 1250MG/50ML (5MG/ML)
10 12MG/ML
11 13.5MG/1.4ML (2.5MG/ML)
12 13.5MG/3.5ML (1MG/ML)
13 1500MCG/VIAL
01 2DISCN
02 11RX
RLD : No
TE Code : AP
Dosage Form : INJECTABLE; INTRATHECAL
Proprietary Name : BACLOFEN
Dosage Strength : 0.5MG/ML
Approval Date : 2019-09-11
Application Number : 210048
RX/OTC/DISCN : RX
RLD : No
TE Code : AP
RLD : No
TE Code : AP
Dosage Form : INJECTABLE; INTRATHECAL
Proprietary Name : BACLOFEN
Dosage Strength : 2MG/ML
Approval Date : 2019-09-11
Application Number : 210048
RX/OTC/DISCN : RX
RLD : No
TE Code : AP
RLD : No
TE Code : AP
Dosage Form : INJECTABLE; INTRATHECAL
Proprietary Name : BACLOFEN
Dosage Strength : 1MG/ML
Approval Date : 2019-07-30
Application Number : 210315
RX/OTC/DISCN : RX
RLD : No
TE Code : AP
RLD : No
TE Code : AP
Dosage Form : INJECTABLE; INTRATHECAL
Proprietary Name : BACLOFEN
Dosage Strength : 0.05MG/ML
Approval Date : 2021-01-15
Application Number : 210777
RX/OTC/DISCN : RX
RLD : No
TE Code : AP
RLD : Yes
TE Code :
Dosage Form : SOLUTION; INTRAVENOUS
Proprietary Name : ANGIOMAX RTU
Dosage Strength : 250MG/50ML (5MG/ML)
Approval Date : 2019-07-25
Application Number : 211215
RX/OTC/DISCN : RX
RLD : Yes
TE Code :
RLD : Yes
TE Code :
Dosage Form : SOLUTION; INTRAVENOUS
Proprietary Name : BORTEZOMIB
Dosage Strength : 3.5MG/3.5ML (1MG/ML)
Approval Date : 2022-07-27
Application Number : 215331
RX/OTC/DISCN : DISCN
RLD : Yes
TE Code :
RLD : Yes
TE Code :
Dosage Form : SOLUTION; INTRAVENOUS
Proprietary Name : BORTEZOMIB
Dosage Strength : 3.5MG/1.4ML (2.5MG/ML)
Approval Date : 2022-07-27
Application Number : 215331
RX/OTC/DISCN : DISCN
RLD : Yes
TE Code :
RLD : No
TE Code : AP
Dosage Form : POWDER; INTRAVENOUS
Proprietary Name : LEVOTHYROXINE SODIUM
Dosage Strength : 100MCG/VIAL
Approval Date : 2018-12-21
Application Number : 208749
RX/OTC/DISCN : RX
RLD : No
TE Code : AP
RLD : No
TE Code : AP
Dosage Form : POWDER; INTRAVENOUS
Proprietary Name : LEVOTHYROXINE SODIUM
Dosage Strength : 200MCG/VIAL
Approval Date : 2018-12-21
Application Number : 208749
RX/OTC/DISCN : RX
RLD : No
TE Code : AP
RLD : No
TE Code : AP
Dosage Form : POWDER; INTRAVENOUS
Proprietary Name : LEVOTHYROXINE SODIUM
Dosage Strength : 500MCG/VIAL
Approval Date : 2018-12-21
Application Number : 208749
RX/OTC/DISCN : RX
RLD : No
TE Code : AP
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