Approvals (Drugs@FDA)

HALCINONIDE

ENCUBE · HALCINONIDE

ANDA217671Generic (ANDA)Prescription
Open FDA's page for this record
Application number
ANDA217671
Sponsor name
ENCUBE
Submissions
  1. Submission type
    ORIG
    Submission number
    1
    Submission status
    AP
    Submission status date
    20240529
    Review priority
    STANDARD
    Submission class code
    UNKNOWN
    Application docs
    1. ID
      78845
      Url
      https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/217671Orig1s000ltr.pdf
      Date
      20240620
      Type
      Letter
Products
  1. Product number
    001
    Reference drug
    No
    Brand name
    HALCINONIDE
    Reference standard
    Yes
    Dosage form
    SOLUTION
    Route
    TOPICAL
    Marketing status
    Prescription
    Te code
    AT
    Active ingredients
    1. Name
      HALCINONIDE
      Strength
      0.1%
Harmonized identifiers (openFDA)
Application number
ANDA217671
Brand name
HALCINONIDE TOPICAL SOLUTION
Generic name
HALCINONIDE TOPICAL
Manufacturer name
INA Pharmaceutics Inc
Product NDC
74157-012
Product type
HUMAN PRESCRIPTION DRUG
Route
TOPICAL
Substance name
HALCINONIDE
RxCUI
310669
SPL ID
2cda4c71-2cf3-26b6-e063-6294a90a8530
SPL set ID
debd165b-118b-4ef0-af7d-3b90a8fd8ded
Package NDC
74157-012-12
Nui
N0000175576, N0000175450
Pharm class epc
Corticosteroid [EPC]
Pharm class moa
Corticosteroid Hormone Receptor Agonists [MoA]
UNII
SI86V6QNEG
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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.