Approvals (Drugs@FDA)

HALOPERIDOL

RUBICON RESEARCH · HALOPERIDOL LACTATE

ANDA218371Generic (ANDA)Prescription
Open FDA's page for this record
Application number
ANDA218371
Sponsor name
RUBICON RESEARCH
Submissions
  1. Submission type
    SUPPL
    Submission number
    1
    Submission status
    AP
    Submission status date
    20250122
    Review priority
    STANDARD
    Submission class code
    LABELING
    Submission class code description
    Labeling
  2. Submission type
    ORIG
    Submission number
    1
    Submission status
    AP
    Submission status date
    20240131
    Review priority
    STANDARD
    Submission class code
    UNKNOWN
Products
  1. Product number
    001
    Reference drug
    No
    Brand name
    HALOPERIDOL
    Reference standard
    No
    Dosage form
    CONCENTRATE
    Route
    ORAL
    Marketing status
    Prescription
    Te code
    AA
    Active ingredients
    1. Name
      HALOPERIDOL LACTATE
      Strength
      EQ 2MG BASE/ML
Harmonized identifiers (openFDA)
Application number
ANDA218371
Brand name
HALOPERIDOL
Generic name
HALOPERIDOL
Manufacturer name
Advagen Pharma Ltd
Product NDC
72888-173
Product type
HUMAN PRESCRIPTION DRUG
Route
ORAL
Substance name
HALOPERIDOL
RxCUI
141935
SPL ID
45c7bbb4-7235-89a8-e063-6394a90a7ea0
SPL set ID
8bfdc739-51b4-4914-9a60-923e83762307
Package NDC
72888-173-47, 72888-173-48
Nui
N0000180182
Pharm class epc
Typical Antipsychotic [EPC]
UNII
J6292F8L3D
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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.