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Approvals (Drugs@FDA)

ESTRADIOL AND LEVONORGESTREL

ZYDUS PHARMS · ESTRADIOL, LEVONORGESTREL

ANDA220407Generic (ANDA)Prescription
Open FDA's page for this record
Application number
ANDA220407
Sponsor name
ZYDUS PHARMS
Submissions
  1. Submission type
    ORIG
    Submission number
    1
    Submission status
    AP
    Submission status date
    20261019
    Review priority
    STANDARD
    Submission class code
    UNKNOWN
Products
  1. Product number
    001
    Reference drug
    No
    Brand name
    ESTRADIOL AND LEVONORGESTREL
    Reference standard
    No
    Dosage form
    FILM, EXTENDED RELEASE
    Route
    TRANSDERMAL
    Marketing status
    Prescription
    Te code
    AB
    Active ingredients
    1. Name
      ESTRADIOL
      Strength
      0.045MG/24HR
    2. Name
      LEVONORGESTREL
      Strength
      0.015MG/24HR
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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.