Approvals (Drugs@FDA)

NELARABINE

MEITHEAL · NELARABINE

ANDA216038Generic (ANDA)Prescription
Open FDA's page for this record
Application number
ANDA216038
Sponsor name
MEITHEAL
Submissions
  1. Submission type
    ORIG
    Submission number
    1
    Submission status
    AP
    Submission status date
    20230110
    Review priority
    STANDARD
    Submission class code
    UNKNOWN
  2. Submission type
    SUPPL
    Submission number
    4
    Submission status
    AP
    Submission status date
    20260901
    Review priority
    STANDARD
    Submission class code
    LABELING
    Submission class code description
    Labeling
Products
  1. Product number
    001
    Reference drug
    No
    Brand name
    NELARABINE
    Reference standard
    No
    Dosage form
    INJECTABLE
    Route
    INTRAVENOUS
    Marketing status
    Prescription
    Te code
    AP
    Active ingredients
    1. Name
      NELARABINE
      Strength
      250MG/50ML (5MG/ML)
Harmonized identifiers (openFDA)
Application number
ANDA216038
Brand name
NELARABINE
Generic name
NELARABINE
Manufacturer name
Meitheal Pharmaceuticals Inc
Product NDC
71288-165
Product type
HUMAN PRESCRIPTION DRUG
Route
INTRAVENOUS
Substance name
NELARABINE
RxCUI
603566
SPL ID
6e728854-7685-4806-8edb-e2a3fc055c7d
SPL set ID
21919314-5c25-49ab-beba-099983ed4a71
Package NDC
71288-165-52, 71288-165-53, 71288-165-54
Nui
N0000000233, N0000175595
Pharm class moa
Nucleic Acid Synthesis Inhibitors [MoA]
Pharm class epc
Nucleoside Metabolic Inhibitor [EPC]
UNII
60158CV180
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Data from openFDA, FDA's public API. FDA says not to rely on it to make decisions about medical care and to treat every result as unvalidated; confirm against FDA's own record and the product labeling. Not medical or legal advice.