Approvals (Drugs@FDA)

FLUOCINONIDE

QUAGEN · FLUOCINONIDE

ANDA216389Generic (ANDA)Prescription
Open FDA's page for this record
Application number
ANDA216389
Sponsor name
QUAGEN
Submissions
  1. Submission type
    ORIG
    Submission number
    1
    Submission status
    AP
    Submission status date
    20250226
    Review priority
    STANDARD
    Submission class code
    UNKNOWN
Products
  1. Product number
    001
    Reference drug
    No
    Brand name
    FLUOCINONIDE
    Reference standard
    No
    Dosage form
    SOLUTION
    Route
    TOPICAL
    Marketing status
    Prescription
    Te code
    AT
    Active ingredients
    1. Name
      FLUOCINONIDE
      Strength
      0.05%
Harmonized identifiers (openFDA)
Application number
ANDA216389
Brand name
FLUOCINONIDE
Generic name
FLUOCINONIDE
Manufacturer name
QUAGEN PHARMACEUTICALS LLC
Product NDC
70752-154
Product type
HUMAN PRESCRIPTION DRUG
Route
TOPICAL
Substance name
FLUOCINONIDE
RxCUI
310364
SPL ID
553fcfd7-2fe8-4538-9fe8-d42a35ab2d48
SPL set ID
272a4467-b5f8-430b-8fab-7fbb07dc8114
Package NDC
70752-154-05
Nui
N0000175576, N0000175450
Pharm class epc
Corticosteroid [EPC]
Pharm class moa
Corticosteroid Hormone Receptor Agonists [MoA]
UNII
2W4A77YPAN
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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.