Approvals (Drugs@FDA)

NEOMYCIN AND POLYMYXIN B SULFATES AND HYDROCORTISONE

ORBICULAR PHARM TECH · HYDROCORTISONE, NEOMYCIN SULFATE, POLYMYXIN B SULFATE

ANDA220938Generic (ANDA)Prescription
Open FDA's page for this record
Application number
ANDA220938
Sponsor name
ORBICULAR PHARM TECH
Submissions
  1. Submission type
    ORIG
    Submission number
    1
    Submission status
    AP
    Submission status date
    20260827
    Review priority
    STANDARD
    Submission class code
    UNKNOWN
Products
  1. Product number
    001
    Reference drug
    No
    Brand name
    NEOMYCIN AND POLYMYXIN B SULFATES AND HYDROCORTISONE
    Reference standard
    No
    Dosage form
    SOLUTION/DROPS
    Route
    OTIC
    Marketing status
    Prescription
    Te code
    AT
    Active ingredients
    1. Name
      HYDROCORTISONE
      Strength
      1%
    2. Name
      NEOMYCIN SULFATE
      Strength
      EQ 3.5MG BASE/ML
    3. Name
      POLYMYXIN B SULFATE
      Strength
      10,000 UNITS/ML
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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.