Approvals (Drugs@FDA)

PANTOPRAZOLE SODIUM

ALEMBIC · PANTOPRAZOLE SODIUM

ANDA219230Generic (ANDA)Prescription
Open FDA's page for this record
Application number
ANDA219230
Sponsor name
ALEMBIC
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
    INJECTABLE
    Route
    INTRAVENOUS
    Marketing status
    Prescription
    Te code
    AP
    Active ingredients
    1. Name
      PANTOPRAZOLE SODIUM
      Strength
      EQ 40MG BASE/VIAL
Harmonized identifiers (openFDA)
Application number
ANDA219230
Brand name
PANTOPRAZOLE SODIUM
Generic name
PANTOPRAZOLE SODIUM INJECTION
Manufacturer name
Alembic Pharmaceuticals Limited, Alembic Pharmaceuticals Inc.
Product NDC
46708-071, 62332-071
Product type
HUMAN PRESCRIPTION DRUG
Route
INTRAVENOUS
Substance name
PANTOPRAZOLE SODIUM
RxCUI
283669
SPL ID
02ee7ed6-217f-4128-bbbb-b9390475a65b, db0264f6-5825-49a1-bb86-746ece155660
SPL set ID
02ee7ed6-217f-4128-bbbb-b9390475a65b, a9e5fac6-2db6-4311-a98b-eb3f0dde19d6
Package NDC
46708-071-01, 46708-071-10, 46708-071-25, 62332-071-01, 62332-071-10, 62332-071-25
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.