Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 201824
Company: MYLAN PHARMS INC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
CLOZAPINE CLOZAPINE 12.5MG TABLET, ORALLY DISINTEGRATING;ORAL None (Tentative Approval) None No No
CLOZAPINE CLOZAPINE 25MG TABLET, ORALLY DISINTEGRATING;ORAL Prescription AB No No
CLOZAPINE CLOZAPINE 100MG 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
09/15/2015 ORIG-2 Tentative Approval Not Applicable

Label is not available on this site.

09/15/2015 ORIG-1 Approval Not Applicable Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/201824Orig1s000ltr.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
01/22/2016 SUPPL-5 Labeling-Package Insert

Label is not available on this site.

01/22/2016 SUPPL-4 Labeling-Package Insert

Label is not available on this site.

CLOZAPINE

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 090308 BARR LABS INC
CLOZAPINE CLOZAPINE 25MG TABLET, ORALLY DISINTEGRATING;ORAL Prescription No AB 201824 MYLAN PHARMS INC
FAZACLO ODT CLOZAPINE 25MG TABLET, ORALLY DISINTEGRATING;ORAL Prescription Yes AB 021590 JAZZ PHARMS III

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 090308 BARR LABS INC
CLOZAPINE CLOZAPINE 100MG TABLET, ORALLY DISINTEGRATING;ORAL Prescription No AB 201824 MYLAN PHARMS INC
FAZACLO ODT CLOZAPINE 100MG TABLET, ORALLY DISINTEGRATING;ORAL Prescription Yes AB 021590 JAZZ PHARMS III

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