Approvals (Drugs@FDA)

ALENDRONATE SODIUM

IPCA LABS LTD · ALENDRONATE SODIUM

ANDA206387Generic (ANDA)Prescription
Open FDA's page for this record
Application number
ANDA206387
Sponsor name
IPCA LABS LTD
Submissions
  1. Submission type
    ORIG
    Submission number
    1
    Submission status
    AP
    Submission status date
    20240604
    Review priority
    STANDARD
    Submission class code
    UNKNOWN
  2. Submission type
    SUPPL
    Submission number
    1
    Submission status
    AP
    Submission status date
    20260415
    Review priority
    STANDARD
    Submission class code
    LABELING
    Submission class code description
    Labeling
Products
  1. Product number
    003
    Reference drug
    No
    Brand name
    ALENDRONATE SODIUM
    Reference standard
    No
    Dosage form
    TABLET
    Route
    ORAL
    Marketing status
    Prescription
    Te code
    AB
    Active ingredients
    1. Name
      ALENDRONATE SODIUM
      Strength
      EQ 40MG BASE
  2. Product number
    001
    Reference drug
    No
    Brand name
    ALENDRONATE SODIUM
    Reference standard
    No
    Dosage form
    TABLET
    Route
    ORAL
    Marketing status
    Prescription
    Te code
    AB
    Active ingredients
    1. Name
      ALENDRONATE SODIUM
      Strength
      EQ 10MG BASE
  3. Product number
    004
    Reference drug
    No
    Brand name
    ALENDRONATE SODIUM
    Reference standard
    No
    Dosage form
    TABLET
    Route
    ORAL
    Marketing status
    Prescription
    Te code
    AB
    Active ingredients
    1. Name
      ALENDRONATE SODIUM
      Strength
      EQ 70MG BASE
  4. Product number
    002
    Reference drug
    No
    Brand name
    ALENDRONATE SODIUM
    Reference standard
    No
    Dosage form
    TABLET
    Route
    ORAL
    Marketing status
    Prescription
    Te code
    AB
    Active ingredients
    1. Name
      ALENDRONATE SODIUM
      Strength
      EQ 35MG 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.