Approvals (Drugs@FDA)

ERIBULIN MESYLATE

CHIA TAI TIANQING · ERIBULIN MESYLATE

ANDA218743Generic (ANDA)Prescription
Open FDA's page for this record
Application number
ANDA218743
Sponsor name
CHIA TAI TIANQING
Submissions
  1. Submission type
    ORIG
    Submission number
    1
    Submission status
    AP
    Submission status date
    20250304
    Review priority
    STANDARD
    Submission class code
    UNKNOWN
Products
  1. Product number
    001
    Reference drug
    No
    Brand name
    ERIBULIN MESYLATE
    Reference standard
    No
    Dosage form
    SOLUTION
    Route
    INTRAVENOUS
    Marketing status
    Prescription
    Te code
    AP
    Active ingredients
    1. Name
      ERIBULIN MESYLATE
      Strength
      1MG/2ML (0.5MG/ML)
Harmonized identifiers (openFDA)
Application number
ANDA218743
Brand name
ERIBULIN MESYLATE
Generic name
ERIBULIN MESYLATE
Manufacturer name
Sun Pharmaceutical Industries Limited, Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
Product NDC
70095-080, 71731-4171
Product type
HUMAN PRESCRIPTION DRUG
Route
INTRAVENOUS
Substance name
ERIBULIN MESYLATE
RxCUI
1045456
SPL ID
2c0e145b-96b0-4f7b-8993-0f5f59afa81d, de53523f-624f-492d-8d2f-027bbd7ce5f3
SPL set ID
2c0e145b-96b0-4f7b-8993-0f5f59afa81d, 8a81f3e9-ac52-4f98-bf62-da7974d012b3
Package NDC
70095-080-01, 71731-4171-1
UNII
AV9U0660CW
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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.