Approvals (Drugs@FDA)

PANTOPRAZOLE SODIUM

AUROBINDO PHARMA LTD · PANTOPRAZOLE SODIUM

ANDA217923Generic (ANDA)Prescription
Open FDA's page for this record
Application number
ANDA217923
Sponsor name
AUROBINDO PHARMA LTD
Submissions
  1. Submission type
    ORIG
    Submission number
    1
    Submission status
    AP
    Submission status date
    20250331
    Review priority
    STANDARD
    Submission class code
    UNKNOWN
Products
  1. Product number
    001
    Reference drug
    No
    Brand name
    PANTOPRAZOLE SODIUM
    Reference standard
    No
    Dosage form
    FOR SUSPENSION, DELAYED RELEASE
    Route
    ORAL
    Marketing status
    Prescription
    Te code
    AB
    Active ingredients
    1. Name
      PANTOPRAZOLE SODIUM
      Strength
      EQ 40MG BASE
Harmonized identifiers (openFDA)
Application number
ANDA217923
Brand name
PANTOPRAZOLE SODIUM
Generic name
PANTOPRAZOLE SODIUM
Manufacturer name
Aurobindo Pharma Limited
Product NDC
59651-671
Product type
HUMAN PRESCRIPTION DRUG
Route
ORAL
Substance name
PANTOPRAZOLE SODIUM
RxCUI
763306
SPL ID
b3cec41e-e98b-470a-8ba2-c31537023989
SPL set ID
b3cec41e-e98b-470a-8ba2-c31537023989
Package NDC
59651-671-30
UNII
6871619Q5X
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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.