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06 Nov 2025
// FDA
https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=217972

02 Oct 2025
// FDA
https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=215324

03 Sep 2025
// FDA
https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=217595
https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=217873

https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=216390
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Regulatory Info : Approved
Registration Country : Sweden
Cilastatin Sodium; Imipenem Monohydrate
Dosage Form : Solution For Injection
Brand Name : Imipenem/Cilastatin Steri...
Dosage Strength : 500mg;500mg
Packaging :
Approval Date : 14-12-2023
Application Number : 2.02E+13
Regulatory Info : Approved
Registration Country : Sweden

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Regulatory Info : Authorized
Registration Country : Spain
Cylastatin Sodium; Imipenem Monohydrate
Dosage Form : Powder For Solution For ...
Brand Name : Imipenem/Cilastatin Steri...
Dosage Strength : 500MG;500MG
Packaging :
Approval Date : 06-09-2024
Application Number : 89645
Regulatory Info : Authorized
Registration Country : Spain

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Regulatory Info : RX
Registration Country : USA
Dosage Form : INJECTABLE;INJECTION
Brand Name : DOXYCYCLINE HYCLATE
Dosage Strength : EQ 100MG BASE/VIAL
Packaging :
Approval Date : 2025-11-06
Application Number : 217972
Regulatory Info : RX
Registration Country : USA

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Regulatory Info : Approved
Registration Country : Sweden
Dosage Form : Powder For Concentrate F...
Brand Name : Ertapenem Steriscience
Dosage Strength : 1g
Packaging :
Approval Date : 02-07-2024
Application Number : 2.02E+13
Regulatory Info : Approved
Registration Country : Sweden

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Regulatory Info : Authorized
Registration Country : Spain
Dosage Form : Powder For Concentrate F...
Brand Name : Ertapenem Steriscience
Dosage Strength : 1G
Packaging :
Approval Date : 05-02-2025
Application Number : 89668
Regulatory Info : Authorized
Registration Country : Spain

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Regulatory Info : Prescription
Registration Country : Denmark
Dosage Form : Powder For Concentrate F...
Brand Name : Ertapenem \"Steriscience\...
Dosage Strength : 1g
Packaging :
Approval Date : 12-09-2024
Application Number : 28106813822
Regulatory Info : Prescription
Registration Country : Denmark

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Regulatory Info : RX
Registration Country : USA
Dosage Form : SOLUTION;INTRAVENOUS
Brand Name : FOCINVEZ
Dosage Strength : EQ 150MG BASE/50ML (EQ...
Packaging :
Approval Date : 2023-08-22
Application Number : 216686
Regulatory Info : RX
Registration Country : USA

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Regulatory Info : Authorised
Registration Country : Malta
Dosage Form : Powder For Solution For ...
Brand Name : Meropenem Steriscience
Dosage Strength : 500MG
Packaging :
Approval Date : 2022-08-11
Application Number :
Regulatory Info : Authorised
Registration Country : Malta

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Regulatory Info : Authorised
Registration Country : Malta
Dosage Form : Powder For Solution For ...
Brand Name : Meropenem Steriscience
Dosage Strength : 1000MG
Packaging :
Approval Date : 2022-08-11
Application Number :
Regulatory Info : Authorised
Registration Country : Malta

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Regulatory Info : Prescription
Registration Country : Estonia
Dosage Form : Injection/Infusion Solut...
Brand Name : Meropenem Steriscience
Dosage Strength : 1g
Packaging :
Approval Date :
Application Number :
Regulatory Info : Prescription
Registration Country : Estonia

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RLD : No
TE Code : AP
Dosage Form : INJECTABLE; INJECTION
Proprietary Name : DOXYCYCLINE HYCLATE
Dosage Strength : EQ 100MG BASE/VIAL
Approval Date : 2025-11-06
Application Number : 217972
RX/OTC/DISCN : RX
RLD : No
TE Code : AP

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RLD : Yes
TE Code :
Dosage Form : SOLUTION; INTRAVENOUS
Proprietary Name : FOCINVEZ
Dosage Strength : EQ 150MG BASE/50ML (EQ 3...
Approval Date : 2023-08-22
Application Number : 216686
RX/OTC/DISCN : RX
RLD : Yes
TE Code :

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RLD : No
TE Code : AP
Dosage Form : SOLUTION; INTRAVENOUS
Proprietary Name : METHYLENE BLUE
Dosage Strength : 50MG/10ML (5MG/ML)
Approval Date : 2024-11-22
Application Number : 216955
RX/OTC/DISCN : RX
RLD : No
TE Code : AP

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RLD : No
TE Code : AP
Dosage Form : INJECTABLE; INJECTION
Proprietary Name : ROCURONIUM BROMIDE
Dosage Strength : 50MG/5ML (10MG/ML)
Approval Date : 2024-07-22
Application Number : 217092
RX/OTC/DISCN : RX
RLD : No
TE Code : AP

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RLD :
TE Code :
Dosage Form : INJECTION; SOLUTION
Proprietary Name : SELENIOUS ACID
Dosage Strength : 600MCG/10ML
Approval Date :
Application Number : 219492
RX/OTC/DISCN :
RLD :
TE Code :

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RLD : No
TE Code : AP
Dosage Form : SOLUTION; INTRAVENOUS
Proprietary Name : SODIUM BICARBONATE
Dosage Strength : 50MEQ/50ML (1MEQ/ML)
Approval Date : 2023-06-28
Application Number : 217594
RX/OTC/DISCN : RX
RLD : No
TE Code : AP

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RLD : No
TE Code : AP
Dosage Form : SOLUTION; INTRAMUSCULAR, INTRA...
Proprietary Name : SUCCINYLCHOLINE CHLORIDE
Dosage Strength : 100MG/5ML (20MG/ML)
Approval Date : 2024-07-09
Application Number : 217873
RX/OTC/DISCN : RX
RLD : No
TE Code : AP

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RLD : No
TE Code :
Dosage Form : INJECTABLE; INJECTION
Proprietary Name : VANCOCIN HYDROCHLORIDE
Dosage Strength : EQ 1GM BASE/VIAL **Feder...
Approval Date : 1986-03-21
Application Number : 60180
RX/OTC/DISCN : DISCN
RLD : No
TE Code :

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RLD : No
TE Code :
Dosage Form : INJECTABLE; INJECTION
Proprietary Name : VANCOCIN HYDROCHLORIDE
Dosage Strength : EQ 500MG BASE/VIAL
Approval Date : 1984-03-15
Application Number : 62476
RX/OTC/DISCN : DISCN
RLD : No
TE Code :

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RLD : No
TE Code :
Dosage Form : INJECTABLE; INJECTION
Proprietary Name : VANCOCIN HYDROCHLORIDE
Dosage Strength : EQ 500MG BASE/VIAL
Approval Date : 1987-03-13
Application Number : 62716
RX/OTC/DISCN : DISCN
RLD : No
TE Code :

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Regulatory Info : Approved
Registration Country : Sweden
Cilastatin Sodium; Imipenem Monohydrate
Dosage Form : Solution For Injection
Dosage Strength : 500mg;500mg
Packaging :
Brand Name : Imipenem/Cilastatin Steriscie...
Approval Date : 14-12-2023
Application Number : 2.02E+13
Regulatory Info : Approved
Registration Country : Sweden

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Regulatory Info : Authorized
Registration Country : Spain
Cylastatin Sodium; Imipenem Monohydrate
Dosage Form : Powder For Solution For Infusi...
Dosage Strength : 500MG;500MG
Packaging :
Brand Name : Imipenem/Cilastatin Steriscie...
Approval Date : 06-09-2024
Application Number : 89645
Regulatory Info : Authorized
Registration Country : Spain

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Regulatory Info : Approved
Registration Country : Sweden
Dosage Form : Powder For Concentrate For Sol...
Dosage Strength : 1g
Packaging :
Brand Name : Ertapenem Steriscience
Approval Date : 02-07-2024
Application Number : 2.02E+13
Regulatory Info : Approved
Registration Country : Sweden

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Regulatory Info : Authorized
Registration Country : Spain
Dosage Form : Powder For Concentrate For Sol...
Dosage Strength : 1G
Packaging :
Brand Name : Ertapenem Steriscience
Approval Date : 05-02-2025
Application Number : 89668
Regulatory Info : Authorized
Registration Country : Spain

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Regulatory Info : Prescription
Registration Country : Denmark
Dosage Form : Powder For Concentrate For Sol...
Dosage Strength : 1g
Packaging :
Brand Name : Ertapenem \"Steriscience\"
Approval Date : 12-09-2024
Application Number : 28106813822
Regulatory Info : Prescription
Registration Country : Denmark

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Regulatory Info : Authorised
Registration Country : Malta
Dosage Form : Powder For Solution For Inject...
Dosage Strength : 500MG
Packaging :
Brand Name : Meropenem Steriscience
Approval Date : 2022-08-11
Application Number :
Regulatory Info : Authorised
Registration Country : Malta

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Regulatory Info : Authorised
Registration Country : Malta
Dosage Form : Powder For Solution For Inject...
Dosage Strength : 1000MG
Packaging :
Brand Name : Meropenem Steriscience
Approval Date : 2022-08-11
Application Number :
Regulatory Info : Authorised
Registration Country : Malta

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Regulatory Info : Prescription
Registration Country : Estonia
Dosage Form : Injection/Infusion Solution
Dosage Strength : 1g
Packaging :
Brand Name : Meropenem Steriscience
Approval Date :
Application Number :
Regulatory Info : Prescription
Registration Country : Estonia

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Regulatory Info : Prescription
Registration Country : Estonia
Dosage Form : Injection/Infusion Solution
Dosage Strength : 500mg
Packaging :
Brand Name : Meropenem Steriscience
Approval Date :
Application Number :
Regulatory Info : Prescription
Registration Country : Estonia

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Regulatory Info : Authorized
Registration Country : Spain
Dosage Form : Powder For Injection And Infus...
Dosage Strength : 2G
Packaging :
Brand Name : Meropenem Steriscience
Approval Date : 05-03-2025
Application Number : 90193
Regulatory Info : Authorized
Registration Country : Spain

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