Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 071196
Company: APOTEX INC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
TRAZODONE HYDROCHLORIDE TRAZODONE HYDROCHLORIDE 100MG TABLET;ORAL Prescription AB No Yes
TRAZODONE HYDROCHLORIDE TRAZODONE HYDROCHLORIDE 150MG TABLET;ORAL Prescription AB No No
TRAZODONE HYDROCHLORIDE TRAZODONE HYDROCHLORIDE 300MG 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
03/25/1987 ORIG-1 Approval

Label is not available on this site.

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
09/11/2014 SUPPL-64 Labeling-Package Insert

Label is not available on this site.

11/19/2013 SUPPL-63 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/071258Orig1s040, 071196Orig1s063lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/071258Orig1s040,071196Orig1s063ltr.pdf
06/02/2015 SUPPL-62 Labeling-Package Insert Label (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/071196s062lbl.pdf
08/11/2008 SUPPL-54 Labeling

Label is not available on this site.

06/25/2007 SUPPL-50 Labeling

Label is not available on this site.

12/05/2005 SUPPL-48 Labeling

Label is not available on this site.

09/09/2005 SUPPL-47 Labeling

Label is not available on this site.

04/08/2005 SUPPL-46 Labeling

Label is not available on this site.

01/21/2003 SUPPL-44 Labeling

Label is not available on this site.

09/13/2000 SUPPL-42 Labeling

Label is not available on this site.

10/25/1999 SUPPL-41 Manufacturing (CMC)-Expiration Date

Label is not available on this site.

12/21/1999 SUPPL-40 Manufacturing (CMC)-Facility

Label is not available on this site.

07/07/2000 SUPPL-39 Manufacturing (CMC)-Control

Label is not available on this site.

05/26/1999 SUPPL-38 Manufacturing (CMC)

Label is not available on this site.

10/25/1999 SUPPL-37 Manufacturing (CMC)-Facility

Label is not available on this site.

05/26/1999 SUPPL-36 Manufacturing (CMC)

Label is not available on this site.

12/01/1998 SUPPL-35 Manufacturing (CMC)

Label is not available on this site.

09/25/1998 SUPPL-34 Manufacturing (CMC)

Label is not available on this site.

04/26/1999 SUPPL-27 Manufacturing (CMC)

Label is not available on this site.

04/26/1999 SUPPL-26 Labeling

Label is not available on this site.

04/26/1999 SUPPL-25 Labeling

Label is not available on this site.

04/26/1999 SUPPL-24 Manufacturing (CMC)

Label is not available on this site.

04/26/1999 SUPPL-23 Manufacturing (CMC)

Label is not available on this site.

04/26/1999 SUPPL-22 Manufacturing (CMC)

Label is not available on this site.

04/26/1999 SUPPL-21 Manufacturing (CMC)

Label is not available on this site.

04/26/1999 SUPPL-20 Manufacturing (CMC)

Label is not available on this site.

04/26/1999 SUPPL-19 Manufacturing (CMC)

Label is not available on this site.

04/26/1999 SUPPL-18 Manufacturing (CMC)

Label is not available on this site.

05/06/1997 SUPPL-15 Manufacturing (CMC)

Label is not available on this site.

09/18/1996 SUPPL-14 Labeling

Label is not available on this site.

12/23/1994 SUPPL-13 Manufacturing (CMC)

Label is not available on this site.

10/11/1994 SUPPL-12 Manufacturing (CMC)

Label is not available on this site.

04/03/1992 SUPPL-11 Manufacturing (CMC)

Label is not available on this site.

04/03/1992 SUPPL-9 Manufacturing (CMC)

Label is not available on this site.

09/23/1991 SUPPL-8 Labeling

Label is not available on this site.

08/06/1991 SUPPL-7 Labeling

Label is not available on this site.

09/20/1988 SUPPL-5 Manufacturing (CMC)

Label is not available on this site.

11/20/1987 SUPPL-1 Manufacturing (CMC)

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
06/02/2015 SUPPL-62 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/071196s062lbl.pdf
11/19/2013 SUPPL-63 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/071258Orig1s040, 071196Orig1s063lbl.pdf

TRAZODONE HYDROCHLORIDE

TABLET;ORAL; 100MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
TRAZODONE HYDROCHLORIDE TRAZODONE HYDROCHLORIDE 100MG TABLET;ORAL Prescription No AB 206923 ACCORD HLTHCARE
TRAZODONE HYDROCHLORIDE TRAZODONE HYDROCHLORIDE 100MG TABLET;ORAL Prescription No AB 071514 ALVOGEN
TRAZODONE HYDROCHLORIDE TRAZODONE HYDROCHLORIDE 100MG TABLET;ORAL Prescription No AB 071196 APOTEX INC
TRAZODONE HYDROCHLORIDE TRAZODONE HYDROCHLORIDE 100MG TABLET;ORAL Prescription No AB 072193 OXFORD PHARMS
TRAZODONE HYDROCHLORIDE TRAZODONE HYDROCHLORIDE 100MG TABLET;ORAL Prescription No AB 073137 SUN PHARM INDUSTRIES
TRAZODONE HYDROCHLORIDE TRAZODONE HYDROCHLORIDE 100MG TABLET;ORAL Prescription No AB 071524 TEVA PHARMS USA
TRAZODONE HYDROCHLORIDE TRAZODONE HYDROCHLORIDE 100MG TABLET;ORAL Prescription No AB 202180 TORRENT
TRAZODONE HYDROCHLORIDE TRAZODONE HYDROCHLORIDE 100MG TABLET;ORAL Prescription No AB 205253 ZYDUS PHARMS

TABLET;ORAL; 150MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
TRAZODONE HYDROCHLORIDE TRAZODONE HYDROCHLORIDE 150MG TABLET;ORAL Prescription No AB 206923 ACCORD HLTHCARE
TRAZODONE HYDROCHLORIDE TRAZODONE HYDROCHLORIDE 150MG TABLET;ORAL Prescription No AB 071196 APOTEX INC
TRAZODONE HYDROCHLORIDE TRAZODONE HYDROCHLORIDE 150MG TABLET;ORAL Prescription No AB 071525 PLIVA
TRAZODONE HYDROCHLORIDE TRAZODONE HYDROCHLORIDE 150MG TABLET;ORAL Prescription No AB 073137 SUN PHARM INDUSTRIES
TRAZODONE HYDROCHLORIDE TRAZODONE HYDROCHLORIDE 150MG TABLET;ORAL Prescription No AB 202180 TORRENT
TRAZODONE HYDROCHLORIDE TRAZODONE HYDROCHLORIDE 150MG TABLET;ORAL Prescription No AB 205253 ZYDUS PHARMS

TABLET;ORAL; 300MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
TRAZODONE HYDROCHLORIDE TRAZODONE HYDROCHLORIDE 300MG TABLET;ORAL Prescription No AB 206923 ACCORD HLTHCARE
TRAZODONE HYDROCHLORIDE TRAZODONE HYDROCHLORIDE 300MG TABLET;ORAL Prescription No AB 071196 APOTEX INC
TRAZODONE HYDROCHLORIDE TRAZODONE HYDROCHLORIDE 300MG TABLET;ORAL Prescription No AB 202180 TORRENT
TRAZODONE HYDROCHLORIDE TRAZODONE HYDROCHLORIDE 300MG TABLET;ORAL Prescription No AB 205253 ZYDUS PHARMS

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