Approvals (Drugs@FDA)

MYCOPHENOLATE SODIUM

FOSUN WANBANG · MYCOPHENOLATE SODIUM

ANDA216637Generic (ANDA)Prescription
Open FDA's page for this record
Application number
ANDA216637
Sponsor name
FOSUN WANBANG
Submissions
  1. Submission type
    SUPPL
    Submission number
    2
    Submission status
    AP
    Submission status date
    20260729
    Submission class code
    REMS
    Submission class code description
    REMS
  2. Submission type
    ORIG
    Submission number
    1
    Submission status
    AP
    Submission status date
    20240529
    Review priority
    STANDARD
    Submission class code
    UNKNOWN
Products
  1. Product number
    001
    Reference drug
    No
    Brand name
    MYCOPHENOLATE SODIUM
    Reference standard
    No
    Dosage form
    TABLET, DELAYED RELEASE
    Route
    ORAL
    Marketing status
    Prescription
    Te code
    AB
    Active ingredients
    1. Name
      MYCOPHENOLATE SODIUM
      Strength
      EQ 180MG BASE
  2. Product number
    002
    Reference drug
    No
    Brand name
    MYCOPHENOLATE SODIUM
    Reference standard
    No
    Dosage form
    TABLET, DELAYED RELEASE
    Route
    ORAL
    Marketing status
    Prescription
    Te code
    AB
    Active ingredients
    1. Name
      MYCOPHENOLATE SODIUM
      Strength
      EQ 360MG BASE
Harmonized identifiers (openFDA)
Application number
ANDA216637
Brand name
MYCOPHENOLIC ACID
Generic name
MYCOPHENOLIC ACID
Manufacturer name
Novugen Pharma (USA) LLC.
Product NDC
82293-012, 82293-013
Product type
HUMAN PRESCRIPTION DRUG
Route
ORAL
Substance name
MYCOPHENOLATE SODIUM
RxCUI
485020, 485023
SPL ID
1f0154d5-686f-170e-e063-6394a90a67e6
SPL set ID
cbc3e916-09e2-4e6e-9e5e-98375f5e6d41
Package NDC
82293-012-10, 82293-013-10
UNII
WX877SQI1G
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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.