Approvals (Drugs@FDA)

PERINDOPRIL ERBUMINE

HIKMA · PERINDOPRIL ERBUMINE

ANDA090072Generic (ANDA)Discontinued
Open FDA's page for this record
Application number
ANDA090072
Sponsor name
HIKMA
Submissions
  1. Submission type
    SUPPL
    Submission number
    8
    Submission status
    AP
    Submission status date
    20161109
    Review priority
    STANDARD
    Submission class code
    LABELING
    Submission class code description
    Labeling
  2. Submission type
    SUPPL
    Submission number
    4
    Submission status
    AP
    Submission status date
    20150504
    Review priority
    STANDARD
    Submission class code
    LABELING
    Submission class code description
    Labeling
  3. Submission type
    SUPPL
    Submission number
    10
    Submission status
    AP
    Submission status date
    20240127
    Review priority
    STANDARD
    Submission class code
    LABELING
    Submission class code description
    Labeling
  4. Submission type
    SUPPL
    Submission number
    2
    Submission status
    AP
    Submission status date
    20150504
    Submission class code
    LABELING
    Submission class code description
    Labeling
  5. Submission type
    SUPPL
    Submission number
    7
    Submission status
    AP
    Submission status date
    20150504
    Review priority
    STANDARD
    Submission class code
    LABELING
    Submission class code description
    Labeling
  6. Submission type
    ORIG
    Submission number
    1
    Submission status
    AP
    Submission status date
    20091110
    Application docs
    1. ID
      9254
      Url
      http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/090072s000ltr.pdf
      Date
      20091113
      Type
      Letter
  7. Submission type
    SUPPL
    Submission number
    1
    Submission status
    AP
    Submission status date
    20110218
    Submission class code
    LABELING
    Submission class code description
    Labeling
Products
  1. Product number
    002
    Reference drug
    No
    Brand name
    PERINDOPRIL ERBUMINE
    Reference standard
    No
    Dosage form
    TABLET
    Route
    ORAL
    Marketing status
    Discontinued
    Te code
    AB
    Active ingredients
    1. Name
      PERINDOPRIL ERBUMINE
      Strength
      4MG
  2. Product number
    003
    Reference drug
    No
    Brand name
    PERINDOPRIL ERBUMINE
    Reference standard
    No
    Dosage form
    TABLET
    Route
    ORAL
    Marketing status
    Discontinued
    Te code
    AB
    Active ingredients
    1. Name
      PERINDOPRIL ERBUMINE
      Strength
      8MG
  3. Product number
    001
    Reference drug
    No
    Brand name
    PERINDOPRIL ERBUMINE
    Reference standard
    No
    Dosage form
    TABLET
    Route
    ORAL
    Marketing status
    Discontinued
    Te code
    AB
    Active ingredients
    1. Name
      PERINDOPRIL ERBUMINE
      Strength
      2MG
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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.