Approvals (Drugs@FDA)

EMTRICITABINE AND TENOFOVIR ALAFENAMIDE FUMARATE

MACLEODS PHARMS · EMTRICITABINE, TENOFOVIR ALAFENAMIDE FUMARATE

ANDA214216Generic (ANDA)Prescription
Open FDA's page for this record
Application number
ANDA214216
Sponsor name
MACLEODS PHARMS
Submissions
  1. Submission type
    ORIG
    Submission number
    1
    Submission status
    AP
    Submission status date
    20260407
    Review priority
    STANDARD
    Submission class code
    UNKNOWN
    Application docs
    1. ID
      81189
      Url
      https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2025/214216Orig1s000TAltr.pdf
      Date
      20250210
      Type
      Letter
Products
  1. Product number
    001
    Reference drug
    No
    Brand name
    EMTRICITABINE AND TENOFOVIR ALAFENAMIDE FUMARATE
    Reference standard
    No
    Dosage form
    TABLET
    Route
    ORAL
    Marketing status
    Prescription
    Te code
    AB
    Active ingredients
    1. Name
      EMTRICITABINE
      Strength
      200MG
    2. Name
      TENOFOVIR ALAFENAMIDE FUMARATE
      Strength
      EQ 25MG BASE
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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.