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

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PharmaCompass

01

  • fda
  • EDQM
  • WHO-GMP

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

RLD : No

TE Code : AP

AZACITIDINE

Brand Name : AZACITIDINE

Dosage Form : POWDER;INTRAVENOUS, SUBCUTANEOUS

Dosage Strength : 100MG/VIAL

Approval Date : 2013-09-16

Application Number : 201537

RX/OTC/DISCN : RX

RLD : No

TE Code : AP

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02

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Not Confirmed
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AZACITIDINE

Brand Name : AZACITIDINE

Dosage Form : POWDER;INTRAVENOUS, SUBCUTANEOUS

Dosage Strength : 100MG/VIAL

Approval Date : 2018-07-02

Application Number : 207475

RX/OTC/DISCN : RX

RLD : No

TE Code : AP

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03

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Not Confirmed
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AZACITIDINE

Brand Name : AZACITIDINE

Dosage Form : POWDER;INTRAVENOUS, SUBCUTANEOUS

Dosage Strength : 100MG/VIAL

Approval Date : 2016-04-29

Application Number : 208216

RX/OTC/DISCN : RX

RLD : No

TE Code : AP

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04

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Not Confirmed
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AZACITIDINE

Brand Name : VIDAZA

Dosage Form : POWDER;INTRAVENOUS, SUBCUTANEOUS

Dosage Strength : 100MG/VIAL

Approval Date : 2004-05-19

Application Number : 50794

RX/OTC/DISCN : RX

RLD : Yes

TE Code : AP

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05

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Not Confirmed
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AZACITIDINE

Brand Name : AZACITIDINE

Dosage Form : POWDER;INTRAVENOUS, SUBCUTANEOUS

Dosage Strength : 100MG/VIAL

Approval Date : 2018-05-04

Application Number : 209540

RX/OTC/DISCN : RX

RLD : No

TE Code : AP

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06

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AZACITIDINE

Brand Name : AZACITIDINE

Dosage Form : POWDER;INTRAVENOUS, SUBCUTANEOUS

Dosage Strength : 100MG/VIAL

Approval Date : 2020-06-08

Application Number : 209337

RX/OTC/DISCN : RX

RLD : No

TE Code : AP

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07

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AZACITIDINE

Brand Name : AZACITIDINE

Dosage Form : POWDER;INTRAVENOUS, SUBCUTANEOUS

Dosage Strength : 100MG/VIAL

Approval Date : 2019-02-27

Application Number : 210748

RX/OTC/DISCN : DISCN

RLD : No

TE Code :

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08

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AZACITIDINE

Brand Name : AZACITIDINE

Dosage Form : POWDER;INTRAVENOUS, SUBCUTANEOUS

Dosage Strength : 100MG/VIAL

Approval Date : 2017-06-23

Application Number : 207234

RX/OTC/DISCN : RX

RLD : No

TE Code : AP

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09

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AZACITIDINE

Brand Name : AZACITIDINE

Dosage Form : POWDER;INTRAVENOUS, SUBCUTANEOUS

Dosage Strength : 100MG/VIAL

Approval Date : 2016-09-29

Application Number : 207518

RX/OTC/DISCN : RX

RLD : No

TE Code : AP

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10

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Not Confirmed
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AZACITIDINE

Brand Name : AZACITIDINE

Dosage Form : POWDER;INTRAVENOUS, SUBCUTANEOUS

Dosage Strength : 100MG/VIAL

Approval Date : 2016-04-28

Application Number : 204949

RX/OTC/DISCN : DISCN

RLD : No

TE Code :

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