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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 212923
Company: AUROBINDO PHARMA

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
CLOZAPINE CLOZAPINE 12.5MG TABLET, ORALLY DISINTEGRATING;ORAL Prescription AB No No
CLOZAPINE CLOZAPINE 25MG TABLET, ORALLY DISINTEGRATING;ORAL Prescription AB No No
CLOZAPINE CLOZAPINE 100MG TABLET, ORALLY DISINTEGRATING;ORAL Prescription AB No No
CLOZAPINE CLOZAPINE 150MG TABLET, ORALLY DISINTEGRATING;ORAL Prescription AB No No
CLOZAPINE CLOZAPINE 200MG TABLET, ORALLY DISINTEGRATING;ORAL Prescription AB No No

Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
12/12/2024 ORIG-1 Approval STANDARD

Label is not available on this site.
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
06/13/2025 SUPPL-3 Labeling-Package Insert

Label is not available on this site.
06/13/2025 SUPPL-2 REMS - MODIFIED - D-N-A

Label is not available on this site.
05/09/2025 SUPPL-1 Labeling-Package Insert

Label is not available on this site.

CLOZAPINE

TABLET, ORALLY DISINTEGRATING;ORAL; 12.5MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
CLOZAPINE CLOZAPINE 12.5MG TABLET, ORALLY DISINTEGRATING;ORAL Prescription No AB 212923 AUROBINDO PHARMA
CLOZAPINE CLOZAPINE 12.5MG TABLET, ORALLY DISINTEGRATING;ORAL Prescription No AB 090308 BARR LABS INC

TABLET, ORALLY DISINTEGRATING;ORAL; 25MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
CLOZAPINE CLOZAPINE 25MG TABLET, ORALLY DISINTEGRATING;ORAL Prescription No AB 212923 AUROBINDO PHARMA
CLOZAPINE CLOZAPINE 25MG TABLET, ORALLY DISINTEGRATING;ORAL Prescription No AB 090308 BARR LABS INC
CLOZAPINE CLOZAPINE 25MG TABLET, ORALLY DISINTEGRATING;ORAL Prescription No AB 201824 MYLAN

TABLET, ORALLY DISINTEGRATING;ORAL; 100MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
CLOZAPINE CLOZAPINE 100MG TABLET, ORALLY DISINTEGRATING;ORAL Prescription No AB 212923 AUROBINDO PHARMA
CLOZAPINE CLOZAPINE 100MG TABLET, ORALLY DISINTEGRATING;ORAL Prescription No AB 090308 BARR LABS INC
CLOZAPINE CLOZAPINE 100MG TABLET, ORALLY DISINTEGRATING;ORAL Prescription No AB 201824 MYLAN

TABLET, ORALLY DISINTEGRATING;ORAL; 150MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
CLOZAPINE CLOZAPINE 150MG TABLET, ORALLY DISINTEGRATING;ORAL Prescription No AB 212923 AUROBINDO PHARMA
CLOZAPINE CLOZAPINE 150MG TABLET, ORALLY DISINTEGRATING;ORAL Prescription No AB 090308 BARR LABS INC
CLOZAPINE CLOZAPINE 150MG TABLET, ORALLY DISINTEGRATING;ORAL Prescription No AB 201824 MYLAN

TABLET, ORALLY DISINTEGRATING;ORAL; 200MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
CLOZAPINE CLOZAPINE 200MG TABLET, ORALLY DISINTEGRATING;ORAL Prescription No AB 212923 AUROBINDO PHARMA
CLOZAPINE CLOZAPINE 200MG TABLET, ORALLY DISINTEGRATING;ORAL Prescription No AB 090308 BARR LABS INC
CLOZAPINE CLOZAPINE 200MG TABLET, ORALLY DISINTEGRATING;ORAL Prescription No AB 201824 MYLAN
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