Approvals (Drugs@FDA)

FAMOTIDINE

CONTRACT PHARMACAL · FAMOTIDINE

ANDA218003Generic (ANDA)Over-the-counter
Open FDA's page for this record
Application number
ANDA218003
Sponsor name
CONTRACT PHARMACAL
Submissions
  1. Submission type
    ORIG
    Submission number
    1
    Submission status
    AP
    Submission status date
    20240528
    Review priority
    STANDARD
    Submission class code
    UNKNOWN
Products
  1. Product number
    002
    Reference drug
    No
    Brand name
    FAMOTIDINE
    Reference standard
    No
    Dosage form
    TABLET
    Route
    ORAL
    Marketing status
    Over-the-counter
    Active ingredients
    1. Name
      FAMOTIDINE
      Strength
      20MG
  2. Product number
    001
    Reference drug
    No
    Brand name
    FAMOTIDINE
    Reference standard
    No
    Dosage form
    TABLET
    Route
    ORAL
    Marketing status
    Over-the-counter
    Active ingredients
    1. Name
      FAMOTIDINE
      Strength
      10MG
Harmonized identifiers (openFDA)
Application number
ANDA218003
Brand name
FAMOTIDINE
Generic name
FAMOTIDINE
Manufacturer name
LEADER/ Cardinal Health 110, Inc.
Product NDC
70000-0710
Product type
HUMAN OTC DRUG
Route
ORAL
Substance name
FAMOTIDINE
RxCUI
310273
SPL ID
2de46de3-c99e-22ea-e063-6394a90a165d
SPL set ID
287525d8-83ef-7110-e063-6294a90ad373
Package NDC
70000-0710-1
Nui
N0000000151, N0000175784
Pharm class moa
Histamine H2 Receptor Antagonists [MoA]
Pharm class epc
Histamine-2 Receptor Antagonist [EPC]
UNII
5QZO15J2Z8
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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.