Approvals (Drugs@FDA)

METHOTREXATE SODIUM

ELITE LABS INC · METHOTREXATE SODIUM

ANDA216453Generic (ANDA)Prescription
Open FDA's page for this record
Application number
ANDA216453
Sponsor name
ELITE LABS INC
Submissions
  1. Submission type
    ORIG
    Submission number
    1
    Submission status
    AP
    Submission status date
    20240516
    Review priority
    STANDARD
    Submission class code
    UNKNOWN
  2. Submission type
    SUPPL
    Submission number
    3
    Submission status
    AP
    Submission status date
    20260527
    Review priority
    STANDARD
    Submission class code
    LABELING
    Submission class code description
    Labeling
Products
  1. Product number
    001
    Reference drug
    No
    Brand name
    METHOTREXATE SODIUM
    Reference standard
    No
    Dosage form
    TABLET
    Route
    ORAL
    Marketing status
    Prescription
    Te code
    AB
    Active ingredients
    1. Name
      METHOTREXATE SODIUM
      Strength
      EQ 2.5MG BASE
Harmonized identifiers (openFDA)
Application number
ANDA216453
Brand name
METHOTREXATE SODIUM
Generic name
METHOTREXATE SODIUM
Manufacturer name
Elite Laboratories, Inc.
Product NDC
64850-330
Product type
HUMAN PRESCRIPTION DRUG
Route
ORAL
Substance name
METHOTREXATE SODIUM
RxCUI
105585
SPL ID
030a6bcf-d482-4c98-9d27-423235cdb930
SPL set ID
89c05ea3-3be1-46dd-b112-29c436fd7289
Package NDC
64850-330-01
UNII
3IG1E710ZN
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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.