Approvals (Drugs@FDA)

TRETINOIN

AUROBINDO PHARMA LTD · TRETINOIN

ANDA218245Generic (ANDA)Prescription
Open FDA's page for this record
Application number
ANDA218245
Sponsor name
AUROBINDO PHARMA LTD
Submissions
  1. Submission type
    ORIG
    Submission number
    1
    Submission status
    AP
    Submission status date
    20250227
    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
      0.025%
Harmonized identifiers (openFDA)
Application number
ANDA218245
Brand name
TRETINOIN
Generic name
TRETINOIN
Manufacturer name
Aurobindo Pharma Limited
Product NDC
59651-713
Product type
HUMAN PRESCRIPTION DRUG
Route
TOPICAL
Substance name
TRETINOIN
RxCUI
313451
SPL ID
50b05c90-bdd9-4766-b285-52bd88c4c740
SPL set ID
dea325b5-3cb8-4ffb-84e9-782f0e3f6b0e
Package NDC
59651-713-14, 59651-713-46
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.