Approvals (Drugs@FDA)

FINGOLIMOD HYDROCHLORIDE

ACCORD HLTHCARE · FINGOLIMOD HYDROCHLORIDE

ANDA207991Generic (ANDA)Prescription
Open FDA's page for this record
Application number
ANDA207991
Sponsor name
ACCORD HLTHCARE
Submissions
  1. Submission type
    SUPPL
    Submission number
    4
    Submission status
    AP
    Submission status date
    20260925
    Review priority
    STANDARD
    Submission class code
    LABELING
    Submission class code description
    Labeling
  2. Submission type
    ORIG
    Submission number
    1
    Submission status
    AP
    Submission status date
    20201028
    Review priority
    STANDARD
    Submission class code
    UNKNOWN
  3. Submission type
    SUPPL
    Submission number
    2
    Submission status
    AP
    Submission status date
    20240530
    Review priority
    STANDARD
    Submission class code
    LABELING
    Submission class code description
    Labeling
  4. Submission type
    SUPPL
    Submission number
    3
    Submission status
    AP
    Submission status date
    20241219
    Review priority
    STANDARD
    Submission class code
    LABELING
    Submission class code description
    Labeling
Products
  1. Product number
    001
    Reference drug
    No
    Brand name
    FINGOLIMOD HYDROCHLORIDE
    Reference standard
    No
    Dosage form
    CAPSULE
    Route
    ORAL
    Marketing status
    Prescription
    Te code
    AB
    Active ingredients
    1. Name
      FINGOLIMOD HYDROCHLORIDE
      Strength
      EQ 0.5MG BASE
Harmonized identifiers (openFDA)
Application number
ANDA207991
Brand name
FINGOLIMOD HYDROCHLORIDE
Generic name
FINGOLIMOD HYDROCHLORIDE
Manufacturer name
Accord Healthcare Inc.
Product NDC
16729-342
Product type
HUMAN PRESCRIPTION DRUG
Route
ORAL
Substance name
FINGOLIMOD HYDROCHLORIDE
RxCUI
1012895
SPL ID
4148bb57-7d2c-1724-e063-6294a90a34fd
SPL set ID
65e59a51-c9c2-47b4-84fc-e0f8879eb26c
Package NDC
16729-342-89, 16729-342-10, 16729-342-15, 16729-342-17, 16729-342-88, 16729-342-87
UNII
G926EC510T
Wholesale access for licensed clinicians.

Free to join: your NPI is checked against the federal registry at signup, then wholesale pricing and the professional shelves open.

Join as a DoctorSell on MedGrid

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.