Approvals (Drugs@FDA)

OLANZAPINE

MACLEODS PHARMS LTD · OLANZAPINE

ANDA202862Generic (ANDA)Prescription
Open FDA's page for this record
Application number
ANDA202862
Sponsor name
MACLEODS PHARMS LTD
Submissions
  1. Submission type
    SUPPL
    Submission number
    10
    Submission status
    AP
    Submission status date
    20211119
    Review priority
    STANDARD
    Submission class code
    LABELING
    Submission class code description
    Labeling
  2. Submission type
    SUPPL
    Submission number
    53
    Submission status
    AP
    Submission status date
    20260106
    Review priority
    STANDARD
    Submission class code
    LABELING
    Submission class code description
    Labeling
  3. Submission type
    SUPPL
    Submission number
    37
    Submission status
    AP
    Submission status date
    20230607
    Review priority
    STANDARD
    Submission class code
    LABELING
    Submission class code description
    Labeling
  4. Submission type
    SUPPL
    Submission number
    25
    Submission status
    AP
    Submission status date
    20211119
    Review priority
    STANDARD
    Submission class code
    LABELING
    Submission class code description
    Labeling
  5. Submission type
    SUPPL
    Submission number
    11
    Submission status
    AP
    Submission status date
    20211119
    Review priority
    STANDARD
    Submission class code
    LABELING
    Submission class code description
    Labeling
  6. Submission type
    SUPPL
    Submission number
    56
    Submission status
    AP
    Submission status date
    20260916
    Review priority
    STANDARD
    Submission class code
    LABELING
    Submission class code description
    Labeling
  7. Submission type
    SUPPL
    Submission number
    5
    Submission status
    AP
    Submission status date
    20151105
    Review priority
    STANDARD
    Submission class code
    LABELING
    Submission class code description
    Labeling
  8. Submission type
    SUPPL
    Submission number
    3
    Submission status
    AP
    Submission status date
    20151105
    Review priority
    UNKNOWN
    Submission class code
    MANUF (CMC)
    Submission class code description
    Manufacturing (CMC)
  9. Submission type
    SUPPL
    Submission number
    1
    Submission status
    AP
    Submission status date
    20151105
    Review priority
    STANDARD
    Submission class code
    LABELING
    Submission class code description
    Labeling
  10. Submission type
    ORIG
    Submission number
    1
    Submission status
    AP
    Submission status date
    20140815
    Submission class code
    UNKNOWN
  11. Submission type
    SUPPL
    Submission number
    34
    Submission status
    AP
    Submission status date
    20230607
    Review priority
    STANDARD
    Submission class code
    LABELING
    Submission class code description
    Labeling
  12. Submission type
    SUPPL
    Submission number
    26
    Submission status
    AP
    Submission status date
    20211119
    Review priority
    STANDARD
    Submission class code
    LABELING
    Submission class code description
    Labeling
  13. +1 more not shown
Products
  1. Product number
    003
    Reference drug
    No
    Brand name
    OLANZAPINE
    Reference standard
    No
    Dosage form
    TABLET
    Route
    ORAL
    Marketing status
    Prescription
    Te code
    AB
    Active ingredients
    1. Name
      OLANZAPINE
      Strength
      7.5MG
  2. Product number
    001
    Reference drug
    No
    Brand name
    OLANZAPINE
    Reference standard
    No
    Dosage form
    TABLET
    Route
    ORAL
    Marketing status
    Prescription
    Te code
    AB
    Active ingredients
    1. Name
      OLANZAPINE
      Strength
      2.5MG
  3. Product number
    006
    Reference drug
    No
    Brand name
    OLANZAPINE
    Reference standard
    No
    Dosage form
    TABLET
    Route
    ORAL
    Marketing status
    Prescription
    Te code
    AB
    Active ingredients
    1. Name
      OLANZAPINE
      Strength
      20MG
  4. Product number
    004
    Reference drug
    No
    Brand name
    OLANZAPINE
    Reference standard
    No
    Dosage form
    TABLET
    Route
    ORAL
    Marketing status
    Prescription
    Te code
    AB
    Active ingredients
    1. Name
      OLANZAPINE
      Strength
      10MG
  5. Product number
    002
    Reference drug
    No
    Brand name
    OLANZAPINE
    Reference standard
    No
    Dosage form
    TABLET
    Route
    ORAL
    Marketing status
    Prescription
    Te code
    AB
    Active ingredients
    1. Name
      OLANZAPINE
      Strength
      5MG
  6. Product number
    005
    Reference drug
    No
    Brand name
    OLANZAPINE
    Reference standard
    No
    Dosage form
    TABLET
    Route
    ORAL
    Marketing status
    Prescription
    Te code
    AB
    Active ingredients
    1. Name
      OLANZAPINE
      Strength
      15MG
Harmonized identifiers (openFDA)
Application number
ANDA202862
Brand name
OLANZAPINE
Generic name
OLANZAPINE
Manufacturer name
Macleods Pharmaceuticals Limited, NorthStar RxLLC
Product NDC
33342-067, 33342-068, 33342-069, 33342-070, 33342-071, 33342-072, 72603-154, 72603-155, 72603-156, 72603-157, 72603-158, 72603-159
Product type
HUMAN PRESCRIPTION DRUG
Route
ORAL
Substance name
OLANZAPINE
RxCUI
200034, 283639, 312077, 312078, 312079, 314154
SPL ID
2b861570-6b18-4b2b-89aa-29ebde7770f5, bfaf4fef-69a8-40e1-b995-899044ad4a39
SPL set ID
8e095987-bdea-42f2-9550-c7155cf07d30, ea3259d5-36ee-4ac9-b849-9625626e2187
Package NDC
33342-067-07, 33342-067-44, 33342-067-12, 33342-067-11, 33342-068-07, 33342-068-44, 33342-068-12, 33342-068-11, 33342-069-07, 33342-069-44, 33342-069-12, 33342-069-11, 33342-070-07, 33342-070-15, 33342-070-12, 33342-070-44, 33342-070-11, 33342-071-07, 33342-071-15, 33342-071-12, 33342-071-44, 33342-071-11, 33342-072-07, 33342-072-15, 33342-072-12, 33342-072-44, 33342-072-11, 72603-154-01, 72603-154-02, 72603-154-03, 72603-155-01, 72603-155-02, 72603-155-03, 72603-156-01, 72603-157-01, 72603-157-02, 72603-157-03, 72603-158-01, 72603-158-02, 72603-159-01 +2 more
Nui
N0000175430
Pharm class epc
Atypical Antipsychotic [EPC]
UNII
N7U69T4SZR
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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.