Approvals (Drugs@FDA)

ISOTRETINOIN

AUROBINDO PHARMA · ISOTRETINOIN

ANDA218194Generic (ANDA)Prescription
Open FDA's page for this record
Application number
ANDA218194
Sponsor name
AUROBINDO PHARMA
Submissions
  1. Submission type
    SUPPL
    Submission number
    6
    Submission status
    AP
    Submission status date
    20261007
    Submission class code
    REMS
    Submission class code description
    REMS
  2. Submission type
    ORIG
    Submission number
    1
    Submission status
    AP
    Submission status date
    20240129
    Review priority
    STANDARD
    Submission class code
    UNKNOWN
  3. Submission type
    SUPPL
    Submission number
    1
    Submission status
    AP
    Submission status date
    20260209
    Submission class code
    REMS
    Submission class code description
    REMS
Products
  1. Product number
    005
    Reference drug
    No
    Brand name
    ISOTRETINOIN
    Reference standard
    No
    Dosage form
    CAPSULE
    Route
    ORAL
    Marketing status
    Prescription
    Te code
    AB2
    Active ingredients
    1. Name
      ISOTRETINOIN
      Strength
      35MG
  2. Product number
    003
    Reference drug
    No
    Brand name
    ISOTRETINOIN
    Reference standard
    No
    Dosage form
    CAPSULE
    Route
    ORAL
    Marketing status
    Prescription
    Te code
    AB2
    Active ingredients
    1. Name
      ISOTRETINOIN
      Strength
      25MG
  3. Product number
    001
    Reference drug
    No
    Brand name
    ISOTRETINOIN
    Reference standard
    No
    Dosage form
    CAPSULE
    Route
    ORAL
    Marketing status
    Prescription
    Te code
    AB2
    Active ingredients
    1. Name
      ISOTRETINOIN
      Strength
      10MG
  4. Product number
    006
    Reference drug
    No
    Brand name
    ISOTRETINOIN
    Reference standard
    No
    Dosage form
    CAPSULE
    Route
    ORAL
    Marketing status
    Prescription
    Te code
    AB2
    Active ingredients
    1. Name
      ISOTRETINOIN
      Strength
      40MG
  5. Product number
    004
    Reference drug
    No
    Brand name
    ISOTRETINOIN
    Reference standard
    No
    Dosage form
    CAPSULE
    Route
    ORAL
    Marketing status
    Prescription
    Te code
    AB2
    Active ingredients
    1. Name
      ISOTRETINOIN
      Strength
      30MG
  6. Product number
    002
    Reference drug
    No
    Brand name
    ISOTRETINOIN
    Reference standard
    No
    Dosage form
    CAPSULE
    Route
    ORAL
    Marketing status
    Prescription
    Te code
    AB2
    Active ingredients
    1. Name
      ISOTRETINOIN
      Strength
      20MG
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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.