Approvals (Drugs@FDA)

AMLODIPINE BESYLATE

IPCA LABS LTD · AMLODIPINE BESYLATE

ANDA210489Generic (ANDA)Prescription
Open FDA's page for this record
Application number
ANDA210489
Sponsor name
IPCA LABS LTD
Submissions
  1. Submission type
    ORIG
    Submission number
    1
    Submission status
    AP
    Submission status date
    20260922
    Review priority
    STANDARD
    Submission class code
    UNKNOWN
Products
  1. Product number
    002
    Reference drug
    No
    Brand name
    AMLODIPINE BESYLATE
    Reference standard
    No
    Dosage form
    TABLET
    Route
    ORAL
    Marketing status
    Prescription
    Te code
    AB
    Active ingredients
    1. Name
      AMLODIPINE BESYLATE
      Strength
      EQ 5MG BASE
  2. Product number
    003
    Reference drug
    No
    Brand name
    AMLODIPINE BESYLATE
    Reference standard
    No
    Dosage form
    TABLET
    Route
    ORAL
    Marketing status
    Prescription
    Te code
    AB
    Active ingredients
    1. Name
      AMLODIPINE BESYLATE
      Strength
      EQ 10MG BASE
  3. Product number
    001
    Reference drug
    No
    Brand name
    AMLODIPINE BESYLATE
    Reference standard
    No
    Dosage form
    TABLET
    Route
    ORAL
    Marketing status
    Prescription
    Te code
    AB
    Active ingredients
    1. Name
      AMLODIPINE BESYLATE
      Strength
      EQ 2.5MG 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.