Approvals (Drugs@FDA)

DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE

ALEMBIC THERAP · DORZOLAMIDE HYDROCHLORIDE, TIMOLOL MALEATE

ANDA216308Generic (ANDA)Prescription
Open FDA's page for this record
Application number
ANDA216308
Sponsor name
ALEMBIC THERAP
Submissions
  1. Submission type
    ORIG
    Submission number
    1
    Submission status
    AP
    Submission status date
    20250218
    Review priority
    STANDARD
    Submission class code
    UNKNOWN
Products
  1. Product number
    001
    Reference drug
    No
    Brand name
    DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE
    Reference standard
    No
    Dosage form
    SOLUTION/DROPS
    Route
    OPHTHALMIC
    Marketing status
    Prescription
    Te code
    AT2
    Active ingredients
    1. Name
      DORZOLAMIDE HYDROCHLORIDE
      Strength
      EQ 2% BASE
    2. Name
      TIMOLOL MALEATE
      Strength
      EQ 0.5% 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.