Approvals (Drugs@FDA)

SUCRALFATE

STRIDES PHARMA · SUCRALFATE

ANDA216474Generic (ANDA)Prescription
Open FDA's page for this record
Application number
ANDA216474
Sponsor name
STRIDES PHARMA
Submissions
  1. Submission type
    ORIG
    Submission number
    1
    Submission status
    AP
    Submission status date
    20240521
    Review priority
    STANDARD
    Submission class code
    UNKNOWN
Products
  1. Product number
    001
    Reference drug
    No
    Brand name
    SUCRALFATE
    Reference standard
    No
    Dosage form
    SUSPENSION
    Route
    ORAL
    Marketing status
    Prescription
    Te code
    AB
    Active ingredients
    1. Name
      SUCRALFATE
      Strength
      1GM/10ML
Harmonized identifiers (openFDA)
Application number
ANDA216474
Brand name
SUCRALFATE
Generic name
SUCRALFATE
Manufacturer name
Strides Pharma Science Limited
Product NDC
64380-149
Product type
HUMAN PRESCRIPTION DRUG
Route
ORAL
Substance name
SUCRALFATE
RxCUI
313123
SPL ID
a60083fe-4fc9-444d-a210-184ca92a4716
SPL set ID
8e25bff2-769e-4bd4-a6de-895c58b840d2
Package NDC
64380-149-02, 64380-149-03, 64380-149-04, 64380-149-05, 64380-149-06, 64380-149-07, 64380-149-01
Nui
N0000175801, M0015420
Pharm class epc
Aluminum Complex [EPC]
Pharm class cs
Organometallic Compounds [CS]
UNII
XX73205DH5
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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.