Approvals (Drugs@FDA)

VALSARTAN

BOSTAL DRUG · VALSARTAN

ANDA205357Generic (ANDA)Prescription
Open FDA's page for this record
Application number
ANDA205357
Sponsor name
BOSTAL DRUG
Submissions
  1. Submission type
    ORIG
    Submission number
    1
    Submission status
    AP
    Submission status date
    20260811
    Review priority
    STANDARD
    Submission class code
    UNKNOWN
Products
  1. Product number
    004
    Reference drug
    No
    Brand name
    VALSARTAN
    Reference standard
    No
    Dosage form
    TABLET
    Route
    ORAL
    Marketing status
    Prescription
    Te code
    AB
    Active ingredients
    1. Name
      VALSARTAN
      Strength
      320MG
  2. Product number
    002
    Reference drug
    No
    Brand name
    VALSARTAN
    Reference standard
    No
    Dosage form
    TABLET
    Route
    ORAL
    Marketing status
    Prescription
    Te code
    AB
    Active ingredients
    1. Name
      VALSARTAN
      Strength
      80MG
  3. Product number
    003
    Reference drug
    No
    Brand name
    VALSARTAN
    Reference standard
    No
    Dosage form
    TABLET
    Route
    ORAL
    Marketing status
    Prescription
    Te code
    AB
    Active ingredients
    1. Name
      VALSARTAN
      Strength
      160MG
  4. Product number
    001
    Reference drug
    No
    Brand name
    VALSARTAN
    Reference standard
    No
    Dosage form
    TABLET
    Route
    ORAL
    Marketing status
    Prescription
    Te code
    AB
    Active ingredients
    1. Name
      VALSARTAN
      Strength
      40MG
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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.