Approvals (Drugs@FDA)

CLOZAPINE

AUROBINDO PHARMA · CLOZAPINE

ANDA212923Generic (ANDA)Prescription
Open FDA's page for this record
Application number
ANDA212923
Sponsor name
AUROBINDO PHARMA
Submissions
  1. Submission type
    ORIG
    Submission number
    1
    Submission status
    AP
    Submission status date
    20241212
    Review priority
    STANDARD
    Submission class code
    UNKNOWN
  2. Submission type
    SUPPL
    Submission number
    2
    Submission status
    AP
    Submission status date
    20250613
    Submission class code
    REMS
    Submission class code description
    REMS
  3. Submission type
    SUPPL
    Submission number
    3
    Submission status
    AP
    Submission status date
    20250613
    Review priority
    STANDARD
    Submission class code
    LABELING
    Submission class code description
    Labeling
  4. Submission type
    SUPPL
    Submission number
    1
    Submission status
    AP
    Submission status date
    20250509
    Review priority
    STANDARD
    Submission class code
    LABELING
    Submission class code description
    Labeling
Products
  1. Product number
    004
    Reference drug
    No
    Brand name
    CLOZAPINE
    Reference standard
    No
    Dosage form
    TABLET, ORALLY DISINTEGRATING
    Route
    ORAL
    Marketing status
    Prescription
    Te code
    AB
    Active ingredients
    1. Name
      CLOZAPINE
      Strength
      150MG
  2. Product number
    002
    Reference drug
    No
    Brand name
    CLOZAPINE
    Reference standard
    No
    Dosage form
    TABLET, ORALLY DISINTEGRATING
    Route
    ORAL
    Marketing status
    Prescription
    Te code
    AB
    Active ingredients
    1. Name
      CLOZAPINE
      Strength
      25MG
  3. Product number
    005
    Reference drug
    No
    Brand name
    CLOZAPINE
    Reference standard
    No
    Dosage form
    TABLET, ORALLY DISINTEGRATING
    Route
    ORAL
    Marketing status
    Prescription
    Te code
    AB
    Active ingredients
    1. Name
      CLOZAPINE
      Strength
      200MG
  4. Product number
    003
    Reference drug
    No
    Brand name
    CLOZAPINE
    Reference standard
    No
    Dosage form
    TABLET, ORALLY DISINTEGRATING
    Route
    ORAL
    Marketing status
    Prescription
    Te code
    AB
    Active ingredients
    1. Name
      CLOZAPINE
      Strength
      100MG
  5. Product number
    001
    Reference drug
    No
    Brand name
    CLOZAPINE
    Reference standard
    No
    Dosage form
    TABLET, ORALLY DISINTEGRATING
    Route
    ORAL
    Marketing status
    Prescription
    Te code
    AB
    Active ingredients
    1. Name
      CLOZAPINE
      Strength
      12.5MG
Harmonized identifiers (openFDA)
Application number
ANDA212923
Brand name
CLOZAPINE
Generic name
CLOZAPINE
Manufacturer name
Aurobindo Pharma Limited
Product NDC
59651-260, 59651-261, 59651-262, 59651-263, 59651-264
Product type
HUMAN PRESCRIPTION DRUG
Route
ORAL
Substance name
CLOZAPINE
RxCUI
476177, 476179, 721773, 996921, 1006801
SPL ID
5fe42ada-7ea2-4b77-bad5-93e1b1fb765d
SPL set ID
caf2d4a6-2a23-4992-a807-560c4204afc4
Package NDC
59651-260-01, 59651-261-01, 59651-261-48, 59651-262-01, 59651-262-48, 59651-263-01, 59651-263-48, 59651-264-01, 59651-264-48
Nui
N0000175430
Pharm class epc
Atypical Antipsychotic [EPC]
UNII
J60AR2IKIC
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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.