Approvals (Drugs@FDA)

PANTOPRAZOLE SODIUM

CIPLA · PANTOPRAZOLE SODIUM

ANDA217458Generic (ANDA)Prescription
Open FDA's page for this record
Application number
ANDA217458
Sponsor name
CIPLA
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
ANDA217458
Brand name
PANTOPRAZOLE SODIUM DELAYED-RELEASE DELAYED RELEASE
Generic name
PANTOPRAZOLE SODIUM GRANULES
Manufacturer name
Cipla USA Inc.
Product NDC
69097-531
Product type
HUMAN PRESCRIPTION DRUG
Route
ORAL
Substance name
PANTOPRAZOLE SODIUM
RxCUI
763306
SPL ID
176f3856-e33d-4fb2-9fe9-72d96c5eabe8
SPL set ID
195e06db-b76c-4470-b6a5-a3979c25046d
Package NDC
69097-531-31, 69097-531-53
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.