Approvals (Drugs@FDA)

MELPHALAN HYDROCHLORIDE

HETERO LABS · MELPHALAN HYDROCHLORIDE

ANDA215024Generic (ANDA)Prescription
Open FDA's page for this record
Application number
ANDA215024
Sponsor name
HETERO LABS
Submissions
  1. Submission type
    ORIG
    Submission number
    1
    Submission status
    AP
    Submission status date
    20240523
    Review priority
    STANDARD
    Submission class code
    UNKNOWN
Products
  1. Product number
    001
    Reference drug
    No
    Brand name
    MELPHALAN HYDROCHLORIDE
    Reference standard
    No
    Dosage form
    INJECTABLE
    Route
    INJECTION
    Marketing status
    Prescription
    Te code
    AP
    Active ingredients
    1. Name
      MELPHALAN HYDROCHLORIDE
      Strength
      EQ 50MG BASE/VIAL
Harmonized identifiers (openFDA)
Application number
ANDA215024
Brand name
MELPHALAN HYDROCHLORIDE
Generic name
MELPHALAN HYDROCHLORIDE
Manufacturer name
Camber Pharmaceuticals, Inc.
Product NDC
31722-362
Product type
HUMAN PRESCRIPTION DRUG
RxCUI
311487
SPL ID
1b6485c8-5ec7-6fbe-e063-6394a90ac531
SPL set ID
24006cbf-4e91-4bb2-9627-25b4ebc9470a
Package NDC
31722-362-31, 31722-360-31, 31722-361-31
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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.