Approvals (Drugs@FDA)

SACUBITRIL AND VALSARTAN

AUROBINDO PHARMA LTD · SACUBITRIL, VALSARTAN

ANDA213631Generic (ANDA)Prescription
Open FDA's page for this record
Application number
ANDA213631
Sponsor name
AUROBINDO PHARMA LTD
Submissions
  1. Submission type
    ORIG
    Submission number
    1
    Submission status
    AP
    Submission status date
    20260902
    Review priority
    STANDARD
    Submission class code
    UNKNOWN
Products
  1. Product number
    003
    Reference drug
    No
    Brand name
    SACUBITRIL AND VALSARTAN
    Reference standard
    No
    Dosage form
    TABLET
    Route
    ORAL
    Marketing status
    Prescription
    Te code
    AB
    Active ingredients
    1. Name
      SACUBITRIL
      Strength
      97MG
    2. Name
      VALSARTAN
      Strength
      103MG
  2. Product number
    001
    Reference drug
    No
    Brand name
    SACUBITRIL AND VALSARTAN
    Reference standard
    No
    Dosage form
    TABLET
    Route
    ORAL
    Marketing status
    Prescription
    Te code
    AB
    Active ingredients
    1. Name
      SACUBITRIL
      Strength
      24MG
    2. Name
      VALSARTAN
      Strength
      26MG
  3. Product number
    002
    Reference drug
    No
    Brand name
    SACUBITRIL AND VALSARTAN
    Reference standard
    No
    Dosage form
    TABLET
    Route
    ORAL
    Marketing status
    Prescription
    Te code
    AB
    Active ingredients
    1. Name
      SACUBITRIL
      Strength
      49MG
    2. Name
      VALSARTAN
      Strength
      51MG
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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.