Approvals (Drugs@FDA)

MERCAPTOPURINE

HIKMA · MERCAPTOPURINE

ANDA216418Generic (ANDA)Prescription
Open FDA's page for this record
Application number
ANDA216418
Sponsor name
HIKMA
Submissions
  1. Submission type
    ORIG
    Submission number
    1
    Submission status
    AP
    Submission status date
    20250226
    Review priority
    STANDARD
    Submission class code
    UNKNOWN
    Application docs
    1. ID
      81461
      Url
      https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2025/216418Orig1s000ltr.pdf
      Date
      20250306
      Type
      Letter
Products
  1. Product number
    001
    Reference drug
    No
    Brand name
    MERCAPTOPURINE
    Reference standard
    No
    Dosage form
    SUSPENSION
    Route
    ORAL
    Marketing status
    Prescription
    Te code
    AB
    Active ingredients
    1. Name
      MERCAPTOPURINE
      Strength
      20MG/ML
Harmonized identifiers (openFDA)
Application number
ANDA216418
Brand name
MERCAPTOPURINE
Generic name
MERCAPTOPURINE
Manufacturer name
Hikma Pharmaceuticals USA Inc.
Product NDC
0054-0879, 0054-4582
Product type
HUMAN PRESCRIPTION DRUG
Route
ORAL
Substance name
MERCAPTOPURINE
RxCUI
1536484
SPL ID
7490a828-2b59-4972-9a51-fe5173e81aec, 7b9eba74-503d-4704-94e9-d52e8701c7bc
SPL set ID
0a366cf3-91f0-4aa4-8f34-a7a27cad8f15, 25b39be7-fe1e-efe6-e063-6294a90a6e8d
Package NDC
0054-0879-49, 0054-4582-49
UNII
E7WED276I5
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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.