Approvals (Drugs@FDA)

TRETINOIN

ENCUBE · TRETINOIN

ANDA217588Generic (ANDA)Prescription
Open FDA's page for this record
Application number
ANDA217588
Sponsor name
ENCUBE
Submissions
  1. Submission type
    ORIG
    Submission number
    1
    Submission status
    AP
    Submission status date
    20250303
    Review priority
    STANDARD
    Submission class code
    UNKNOWN
Products
  1. Product number
    001
    Reference drug
    No
    Brand name
    TRETINOIN
    Reference standard
    No
    Dosage form
    GEL
    Route
    TOPICAL
    Marketing status
    Prescription
    Te code
    AB
    Active ingredients
    1. Name
      TRETINOIN
      Strength
      0.01%
Harmonized identifiers (openFDA)
Application number
ANDA217588
Brand name
TRETINOIN
Generic name
TRETINOIN
Manufacturer name
Encube Ethicals, Inc.
Product NDC
21922-056, 21922-057
Product type
HUMAN PRESCRIPTION DRUG
Route
TOPICAL
Substance name
TRETINOIN
RxCUI
313450, 313451
SPL ID
09404f33-7d64-49aa-831d-7bb2e2fe3c9a
SPL set ID
b61f6b02-6171-4da8-94eb-bcd4808dd918
Package NDC
21922-057-04, 21922-057-06, 21922-056-04, 21922-056-06
Nui
N0000175607, M0018962
Pharm class epc
Retinoid [EPC]
Pharm class cs
Retinoids [CS]
UNII
5688UTC01R
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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.