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01 4BACLOFEN
02 1BIVALIRUDIN
03 2BORTEZOMIB
04 2DAPTOMYCIN
05 3LEVOTHYROXINE SODIUM
06 1SINCALIDE
07 2SODIUM BENZOATE; SODIUM PHENYLACETATE
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01 15MAIA PHARMS INC
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01 4INJECTABLE;INTRATHECAL
02 6POWDER;INTRAVENOUS
03 5SOLUTION;INTRAVENOUS
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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 1350MG/VIAL
14 1500MCG/VIAL
15 1500MG/VIAL
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01 15USA
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Regulatory Info : RX
Registration Country : USA
Dosage Form : INJECTABLE;INTRATHECAL
Brand Name : BACLOFEN
Dosage Strength : 0.5MG/ML
Packaging :
Approval Date : 2019-09-11
Application Number : 210048
Regulatory Info : RX
Registration Country : USA

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Regulatory Info : RX
Registration Country : USA
Dosage Form : INJECTABLE;INTRATHECAL
Brand Name : BACLOFEN
Dosage Strength : 2MG/ML
Packaging :
Approval Date : 2019-09-11
Application Number : 210048
Regulatory Info : RX
Registration Country : USA

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Regulatory Info : RX
Registration Country : USA
Dosage Form : INJECTABLE;INTRATHECAL
Brand Name : BACLOFEN
Dosage Strength : 1MG/ML
Packaging :
Approval Date : 2019-07-30
Application Number : 210315
Regulatory Info : RX
Registration Country : USA

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Regulatory Info : RX
Registration Country : USA
Dosage Form : INJECTABLE;INTRATHECAL
Brand Name : BACLOFEN
Dosage Strength : 0.05MG/ML
Packaging :
Approval Date : 2021-01-15
Application Number : 210777
Regulatory Info : RX
Registration Country : USA

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Regulatory Info : RX
Registration Country : USA
Dosage Form : SOLUTION;INTRAVENOUS
Brand Name : ANGIOMAX RTU
Dosage Strength : 250MG/50ML (5MG/ML)
Packaging :
Approval Date : 2019-07-25
Application Number : 211215
Regulatory Info : RX
Registration Country : USA

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Regulatory Info : DISCN
Registration Country : USA
Dosage Form : SOLUTION;INTRAVENOUS
Brand Name : BORTEZOMIB
Dosage Strength : 3.5MG/3.5ML (1MG/ML)
Packaging :
Approval Date : 2022-07-27
Application Number : 215331
Regulatory Info : DISCN
Registration Country : USA

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Regulatory Info : DISCN
Registration Country : USA
Dosage Form : SOLUTION;INTRAVENOUS
Brand Name : BORTEZOMIB
Dosage Strength : 3.5MG/1.4ML (2.5MG/ML)
Packaging :
Approval Date : 2022-07-27
Application Number : 215331
Regulatory Info : DISCN
Registration Country : USA

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Regulatory Info : DISCN
Registration Country : USA
Dosage Form : POWDER;INTRAVENOUS
Brand Name : DAPTOMYCIN
Dosage Strength : 350MG/VIAL
Packaging :
Approval Date : 2024-11-21
Application Number : 217630
Regulatory Info : DISCN
Registration Country : USA

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Regulatory Info : RX
Registration Country : USA
Dosage Form : POWDER;INTRAVENOUS
Brand Name : DAPTOMYCIN
Dosage Strength : 500MG/VIAL
Packaging :
Approval Date : 2024-11-21
Application Number : 217630
Regulatory Info : RX
Registration Country : USA

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Regulatory Info : RX
Registration Country : USA
Dosage Form : POWDER;INTRAVENOUS
Brand Name : LEVOTHYROXINE SODIUM
Dosage Strength : 100MCG/VIAL
Packaging :
Approval Date : 2018-12-21
Application Number : 208749
Regulatory Info : RX
Registration Country : USA
