Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 203039
Company: TEVA PHARMS USA
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
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
11/25/2015 ORIG-1 Approval Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/203039Orig1s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/203039Orig1s000ltr.pdf
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
11/25/2015 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/203039Orig1s000lbl.pdf

CLOZAPINE

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 203039 TEVA PHARMS USA
FAZACLO ODT CLOZAPINE 150MG TABLET, ORALLY DISINTEGRATING;ORAL Prescription Yes AB 021590 JAZZ PHARMS III

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 203039 TEVA PHARMS USA
FAZACLO ODT CLOZAPINE 200MG TABLET, ORALLY DISINTEGRATING;ORAL Prescription Yes AB 021590 JAZZ PHARMS III

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