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Approved Drug Products containing Icatibant listed in the FDA Orange Book. Original Data : FDA Website

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  • fda
  • EDQM
  • WHO-GMP

Virtual BoothDRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.

RLD : No

TE Code :

ICATIBANT ACETATE

Brand Name : ICATIBANT ACETATE

Dosage Form : INJECTABLE;SUBCUTANEOUS

Dosage Strength : EQ 30MG BASE/3ML (EQ 10MG BASE/ML)

Approval Date : 2020-10-05

Application Number : 213054

RX/OTC/DISCN : DISCN

RLD : No

TE Code :

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02

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ICATIBANT ACETATE

Brand Name : ICATIBANT ACETATE

Dosage Form : INJECTABLE;SUBCUTANEOUS

Dosage Strength : EQ 30MG BASE/3ML (EQ 10MG BASE/ML)

Approval Date : 2023-08-14

Application Number : 213521

RX/OTC/DISCN : RX

RLD : No

TE Code : AP

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ICATIBANT ACETATE

Brand Name : ICATIBANT ACETATE

Dosage Form : INJECTABLE;SUBCUTANEOUS

Dosage Strength : EQ 30MG BASE/3ML (EQ 10MG BASE/ML)

Approval Date : 2020-07-13

Application Number : 212446

RX/OTC/DISCN : RX

RLD : No

TE Code : AP

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ICATIBANT ACETATE

Brand Name : ICATIBANT ACETATE

Dosage Form : INJECTABLE;SUBCUTANEOUS

Dosage Strength : EQ 30MG BASE/3ML (EQ 10MG BASE/ML)

Approval Date : 2020-06-18

Application Number : 208317

RX/OTC/DISCN : RX

RLD : No

TE Code : AP

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ICATIBANT ACETATE

Brand Name : ICATIBANT ACETATE

Dosage Form : INJECTABLE;SUBCUTANEOUS

Dosage Strength : EQ 30MG BASE/3ML (EQ 10MG BASE/ML)

Approval Date : 2021-05-21

Application Number : 213222

RX/OTC/DISCN : DISCN

RLD : No

TE Code :

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ICATIBANT ACETATE

Brand Name : ICATIBANT ACETATE

Dosage Form : INJECTABLE;SUBCUTANEOUS

Dosage Strength : EQ 30MG BASE/3ML (EQ 10MG BASE/ML)

Approval Date : 2020-03-09

Application Number : 211021

RX/OTC/DISCN : RX

RLD : No

TE Code : AP

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07

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ICATIBANT ACETATE

Brand Name : ICATIBANT ACETATE

Dosage Form : INJECTABLE;SUBCUTANEOUS

Dosage Strength : EQ 30MG BASE/3ML (EQ 10MG BASE/ML)

Approval Date : 2020-12-16

Application Number : 212081

RX/OTC/DISCN : RX

RLD : No

TE Code : AP

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ICATIBANT ACETATE

Brand Name : FIRAZYR

Dosage Form : INJECTABLE;SUBCUTANEOUS

Dosage Strength : EQ 30MG BASE/3ML (EQ 10MG BASE/ML)

Approval Date : 2011-08-25

Application Number : 22150

RX/OTC/DISCN : RX

RLD : Yes

TE Code : AP

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ICATIBANT ACETATE

Brand Name : ICATIBANT ACETATE

Dosage Form : INJECTABLE;SUBCUTANEOUS

Dosage Strength : EQ 30MG BASE/3ML (EQ 10MG BASE/ML)

Approval Date : 2019-07-15

Application Number : 210118

RX/OTC/DISCN : RX

RLD : No

TE Code : AP

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ICATIBANT ACETATE

Brand Name : ICATIBANT ACETATE

Dosage Form : INJECTABLE;SUBCUTANEOUS

Dosage Strength : EQ 30MG BASE/3ML (EQ 10MG BASE/ML)

Approval Date : 2020-09-01

Application Number : 211501

RX/OTC/DISCN : RX

RLD : No

TE Code : AP

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