Drugs@FDA: FDA Approved Drug Products

Home | Previous Page

Abbreviated New Drug Application (ANDA): 202873
Company: ACCORD HLTHCARE
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
CLOZAPINE CLOZAPINE 25MG TABLET;ORAL Prescription AB No No
CLOZAPINE CLOZAPINE 100MG TABLET;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 Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/202873Orig1s000ltr.pdf

CLOZAPINE

TABLET;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;ORAL Prescription No AB 202873 ACCORD HLTHCARE
CLOZAPINE CLOZAPINE 25MG TABLET;ORAL Prescription No AB 206433 AUROBINDO PHARMA LTD
CLOZAPINE CLOZAPINE 25MG TABLET;ORAL Prescription No AB 074949 IVAX SUB TEVA PHARMS
CLOZAPINE CLOZAPINE 25MG TABLET;ORAL Prescription No AB 203807 MAYNE PHARMA
CLOZAPINE CLOZAPINE 25MG TABLET;ORAL Prescription No AB 075417 MYLAN
CLOZAPINE CLOZAPINE 25MG TABLET;ORAL Prescription No AB 075713 SUN PHARM INDS INC
CLOZARIL CLOZAPINE 25MG TABLET;ORAL Prescription Yes AB 019758 HERITAGE LIFE

TABLET;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;ORAL Prescription No AB 202873 ACCORD HLTHCARE
CLOZAPINE CLOZAPINE 100MG TABLET;ORAL Prescription No AB 206433 AUROBINDO PHARMA LTD
CLOZAPINE CLOZAPINE 100MG TABLET;ORAL Prescription No AB 074949 IVAX SUB TEVA PHARMS
CLOZAPINE CLOZAPINE 100MG TABLET;ORAL Prescription No AB 076809 IVAX SUB TEVA PHARMS
CLOZAPINE CLOZAPINE 100MG TABLET;ORAL Prescription No AB 203807 MAYNE PHARMA
CLOZAPINE CLOZAPINE 100MG TABLET;ORAL Prescription No AB 075417 MYLAN
CLOZAPINE CLOZAPINE 100MG TABLET;ORAL Prescription No AB 075713 SUN PHARM INDS INC
CLOZARIL CLOZAPINE 100MG TABLET;ORAL Prescription Yes AB 019758 HERITAGE LIFE

Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players.
Language Assistance Available: Español | 繁體中文 | Tiếng Việt | 한국어 | Tagalog | Русский | العربية | Kreyòl Ayisyen | Français | Polski | Português | Italiano | Deutsch | 日本語 | فارسی | English