Drugs@FDA: FDA-Approved Drugs

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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 None No No
CLOZAPINE CLOZAPINE 200MG TABLET, ORALLY DISINTEGRATING;ORAL Prescription None 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
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
07/29/2021 SUPPL-10 REMS - MODIFIED - D-N-A

Label is not available on this site.

02/18/2021 SUPPL-9 REMS - MODIFIED - D-N-A

Label is not available on this site.

04/16/2021 SUPPL-8 Labeling-Package Insert

Label is not available on this site.

01/16/2019 SUPPL-5 REMS - MODIFIED - D-N-A

Label is not available on this site.

04/16/2021 SUPPL-2 Labeling-Package Insert

Label is not available on this site.

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

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