Approvals (Drugs@FDA)

QUETIAPINE FUMARATE

IPCA LABS LTD · QUETIAPINE FUMARATE

ANDA205983Generic (ANDA)Discontinued
Open FDA's page for this record
Application number
ANDA205983
Sponsor name
IPCA LABS LTD
Submissions
  1. Submission type
    ORIG
    Submission number
    1
    Submission status
    AP
    Submission status date
    20240520
    Review priority
    STANDARD
    Submission class code
    UNKNOWN
  2. Submission type
    SUPPL
    Submission number
    1
    Submission status
    AP
    Submission status date
    20250728
    Review priority
    STANDARD
    Submission class code
    LABELING
    Submission class code description
    Labeling
Products
  1. Product number
    004
    Reference drug
    No
    Brand name
    QUETIAPINE FUMARATE
    Reference standard
    No
    Dosage form
    TABLET
    Route
    ORAL
    Marketing status
    Discontinued
    Te code
    AB
    Active ingredients
    1. Name
      QUETIAPINE FUMARATE
      Strength
      EQ 200MG BASE
  2. Product number
    002
    Reference drug
    No
    Brand name
    QUETIAPINE FUMARATE
    Reference standard
    No
    Dosage form
    TABLET
    Route
    ORAL
    Marketing status
    Discontinued
    Te code
    AB
    Active ingredients
    1. Name
      QUETIAPINE FUMARATE
      Strength
      EQ 50MG BASE
  3. Product number
    005
    Reference drug
    No
    Brand name
    QUETIAPINE FUMARATE
    Reference standard
    No
    Dosage form
    TABLET
    Route
    ORAL
    Marketing status
    Discontinued
    Te code
    AB
    Active ingredients
    1. Name
      QUETIAPINE FUMARATE
      Strength
      EQ 300MG BASE
  4. Product number
    003
    Reference drug
    No
    Brand name
    QUETIAPINE FUMARATE
    Reference standard
    No
    Dosage form
    TABLET
    Route
    ORAL
    Marketing status
    Discontinued
    Te code
    AB
    Active ingredients
    1. Name
      QUETIAPINE FUMARATE
      Strength
      EQ 100MG BASE
  5. Product number
    001
    Reference drug
    No
    Brand name
    QUETIAPINE FUMARATE
    Reference standard
    No
    Dosage form
    TABLET
    Route
    ORAL
    Marketing status
    Discontinued
    Te code
    AB
    Active ingredients
    1. Name
      QUETIAPINE FUMARATE
      Strength
      EQ 25MG BASE
  6. Product number
    006
    Reference drug
    No
    Brand name
    QUETIAPINE FUMARATE
    Reference standard
    No
    Dosage form
    TABLET
    Route
    ORAL
    Marketing status
    Discontinued
    Te code
    AB
    Active ingredients
    1. Name
      QUETIAPINE FUMARATE
      Strength
      EQ 400MG BASE
Wholesale access for licensed clinicians.

Free to join: your NPI is checked against the federal registry at signup, then wholesale pricing and the professional shelves open.

Join as a DoctorSell on MedGrid

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.