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LABELS · 36080e4e-a0fe-ba15-e063-6394a90aed5c

Azacitidine

Open original source → · Download preserved record

Preserved label snapshot, not confirmation of a current approved indication. Approval/withdrawal status must be checked for the exact disease, setting and regimen.

Label effective date
2025-05-26
Captured
2026-09-09T23:37:42.544548+00:00
Current indication reconciliation
Not reconciled

Indications and usage: exact source text

  1. 1 INDICATIONS AND USAGE Azacitidine for Injection is a nucleoside metabolic inhibitor indicated for the treatment of adult patients with the following FAB myelodysplastic syndrome (MDS) subtypes: Refractory anemia (RA) or refractory anemia with ringed sideroblasts (RARS) (if accompanied by neutropenia or thrombocytopenia or requiring transfusions), refractory anemia with excess blasts (RAEB), refractory anemia with excess blasts in transformation (RAEB-T), and chronic myelomonocytic leukemia (CMMoL) ( 1 ). 1.1 Myelodysplastic Syndromes (MDS) Azacitidine for Injection is indicated for treatment of adult patients with the following French-American-British (FAB) myelodysplastic syndrome subtypes: refractory anemia (RA) or refractory anemia with ringed sideroblasts (if accompanied by neutropenia or thrombocytopenia or requiring transfusions), refractory anemia with excess blasts (RAEB), refractory anemia with excess blasts in transformation (RAEB-T), and chronic myelomonocytic leukemia (CMMoL). Pediatric use information is approved for Celgene Corporation’s Vidaza ® (azacitidine for injection). However due to Celgene Corporation’s marketing exclusivity rights, this drug product is not labeled with that information.
Full extracted label fields
application numbers
  1. NDA208216
boxed warning exact
    brand names
    1. Azacitidine
    current indication status
    not_reconciled
    dailymed set url
    https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=5f0f9ee3-a5b1-4a25-a34c-7f38c8433f4a
    generic names
    1. AZACITIDINE
    id
    36080e4e-a0fe-ba15-e063-6394a90aed5c
    indications and usage exact
    1. 1 INDICATIONS AND USAGE Azacitidine for Injection is a nucleoside metabolic inhibitor indicated for the treatment of adult patients with the following FAB myelodysplastic syndrome (MDS) subtypes: Refractory anemia (RA) or refractory anemia with ringed sideroblasts (RARS) (if accompanied by neutropenia or thrombocytopenia or requiring transfusions), refractory anemia with excess blasts (RAEB), refractory anemia with excess blasts in transformation (RAEB-T), and chronic myelomonocytic leukemia (CMMoL) ( 1 ). 1.1 Myelodysplastic Syndromes (MDS) Azacitidine for Injection is indicated for treatment of adult patients with the following French-American-British (FAB) myelodysplastic syndrome subtypes: refractory anemia (RA) or refractory anemia with ringed sideroblasts (if accompanied by neutropenia or thrombocytopenia or requiring transfusions), refractory anemia with excess blasts (RAEB), refractory anemia with excess blasts in transformation (RAEB-T), and chronic myelomonocytic leukemia (CMMoL). Pediatric use information is approved for Celgene Corporation’s Vidaza ® (azacitidine for injection). However due to Celgene Corporation’s marketing exclusivity rights, this drug product is not labeled with that information.
    indications and usage tables exact
      is original packager
      1. true
      manufacturer names
      1. BluePoint Laboratories
      matched search terms
      1. leukemia
      2. myelodysplastic
      package ndcs
      1. 68001-313-56
      product ndcs
      1. 68001-313
      product types
      1. HUMAN PRESCRIPTION DRUG
      recent major changes exact
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        1. INTRAVENOUS
        2. SUBCUTANEOUS
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        1. 485246
        source batch
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        meta
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        source url
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        1. AZACITIDINE
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        Drugs@FDA application source records
        1. application number
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          payload
          all indexed label documents
          1. Appl No
            208216
            Application Docs Date
            2016-05-03 00:00:00
            Application Docs ID
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            Application Docs Title
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            Application Docs Type ID
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            Submission No
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          2. Appl No
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            Application Docs Date
            2018-01-11 00:00:00
            Application Docs ID
            51027
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            Application Docs Type ID
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            Submission No
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          3. Appl No
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            Application Docs Date
            2018-10-24 00:00:00
            Application Docs ID
            56091
            Application Docs Title
            0
            Application Docs Type ID
            2
            Submission No
            2
            Submission Type
            SUPPL
          4. Appl No
            208216
            Application Docs Date
            2020-07-14 00:00:00
            Application Docs ID
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            0
            Application Docs Type ID
            2
            Submission No
            5
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          5. Appl No
            208216
            Application Docs Date
            2023-06-09 00:00:00
            Application Docs ID
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            0
            Application Docs Type ID
            2
            Submission No
            6
            Submission Type
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          6. Appl No
            208216
            Application Docs Date
            2024-12-23 00:00:00
            Application Docs ID
            80681
            Application Docs Title
            0
            Application Docs Type ID
            2
            Submission No
            7
            Submission Type
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            Submission Class Code ID
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            Submission No
            1
            Submission Status
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            Submission Status Date
            2016-04-29 00:00:00
            Submission Type
            ORIG
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          2. Appl No
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            Review Priority
            STANDARD
            Submission Class Code ID
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            Submission No
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            Submission Status Date
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            Submissions Public Notes
          3. Appl No
            208216
            Review Priority
            STANDARD
            Submission Class Code ID
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            Submission No
            2
            Submission Status
            AP
            Submission Status Date
            2018-10-22 00:00:00
            Submission Type
            SUPPL
            Submissions Public Notes
          4. Appl No
            208216
            Review Priority
            STANDARD
            Submission Class Code ID
            3
            Submission No
            5
            Submission Status
            AP
            Submission Status Date
            2020-07-13 00:00:00
            Submission Type
            SUPPL
            Submissions Public Notes
          5. Appl No
            208216
            Review Priority
            STANDARD
            Submission Class Code ID
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            Submission No
            6
            Submission Status
            AP
            Submission Status Date
            2023-06-08 00:00:00
            Submission Type
            SUPPL
            Submissions Public Notes
          6. Appl No
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            Submission Class Code ID
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            Submission No
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            Submission Status
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            Submission Status Date
            2024-12-19 00:00:00
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          application number
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          approval interpretation
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          1. Appl No
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            Application Docs Date
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            Submission No
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          Appl No
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          Sponsor Name
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          openfda application present
          true
          products
          1. Active Ingredient
            AZACITIDINE
            Appl No
            208216
            Drug Name
            AZACITIDINE
            Form
            POWDER;INTRAVENOUS, SUBCUTANEOUS
            Product No
            001
            Reference Drug
            0
            Reference Standard
            0
            Strength
            100MG/VIAL
            marketing status
            1. Prescription

        Source passages and status connections

        Passage classifications are automated and are not treatment recommendations. Connections apply only to their recorded indication scope.

        Passage 1 · positive indication candidate
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        1 INDICATIONS AND USAGE Azacitidine for Injection is a nucleoside metabolic inhibitor indicated for the treatment of adult patients with the following FAB myelodysplastic syndrome (MDS) subtypes: Refractory anemia (RA) or refractory anemia with ringed sideroblasts (RARS) (if accompanied by neutropenia or thrombocytopenia or requiring transfusions), refractory anemia with excess blasts (RAEB), refractory anemia with excess blasts in transformation (RAEB-T), and chronic myelomonocytic leukemia (CMMoL) ( 1 ). 1.1 Myelodysplastic Syndromes (MDS) Azacitidine for Injection is indicated for treatment of adult patients with the following French-American-British (FAB) myelodysplastic syndrome subtypes: refracto
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        is a nucleoside metabolic inhibitor indicated
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          CATIONS AND USAGE Azacitidine for Injection is a nucleoside metabolic inhibitor indicated for the treatment of adult patients with the following FAB myelodysplasti
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            1 INDICATIONS AND USAGE Azacitidine for Injection is a nucleoside metabolic inhibitor indicated for the treatment of adult patients with the following FAB myelodysplastic syndrome (MDS) subtypes: Refractory anemia (RA) or refractory anemia with ringed sideroblasts (RARS) (if accompanied by neutropenia or thrombocytopenia or requiring transfusions), refractory anemia with excess blasts (RAEB), refractory anemia with excess blasts in transformation (RAEB-T), and chronic myelomonocytic leukemia (CMMoL) ( 1 ).
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            ocytopenia or requiring transfusions), refractory anemia with excess blasts (RAEB), refractory anemia with excess blasts in transformation (RAEB-T), and chronic myelomonocytic leukemia (CMMoL) ( 1 ). 1.1 Myelodysplastic Syndromes (MDS) Azacitidine for Injection is indicated for treatment of adult patients with the following French-American-British (FAB) myelodysplastic syndrome subtypes: refractory anemia (RA) or refractory anemia with ringed sideroblasts (if accompanied by neutropenia or thrombocytopenia or requiring transfusions), refractory anemia with excess blasts (RAEB), refractory anemia with excess blasts in transformation (RAEB-T), and chronic myelomonocytic leukemia (CMMoL). Pediatric use information is approved for Celgene Corporation’s Vidaza ® (azacitidine for injection). However due to Celgene Corporation’s marketing exclusivity rights, this drug product is not label
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                1.1 Myelodysplastic Syndromes (MDS) Azacitidine for Injection is indicated for treatment of adult patients with the following French-American-British (FAB) myelodysplastic syndrome subtypes: refractory anemia (RA) or refractory anemia with ringed sideroblasts (if accompanied by neutropenia or thrombocytopenia or requiring transfusions), refractory anemia with excess blasts (RAEB), refractory anemia with excess blasts in transformation (RAEB-T), and chronic myelomonocytic leukemia (CMMoL).
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                          Preserved source evidence · Not medical advice