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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 072193
Company: OXFORD PHARMS
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
TRAZODONE HYDROCHLORIDE TRAZODONE HYDROCHLORIDE 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
02/02/1989 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
05/19/2020 SUPPL-56 Labeling-Package Insert

Label is not available on this site.

05/19/2020 SUPPL-53 Labeling-Medication Guide, Labeling-Package Insert

Label is not available on this site.

06/05/2015 SUPPL-48 Labeling-Package Insert

Label is not available on this site.

05/12/2015 SUPPL-41 Labeling

Label is not available on this site.

10/29/2007 SUPPL-40 Labeling

Label is not available on this site.

06/26/2007 SUPPL-39 Labeling

Label is not available on this site.

08/15/2005 SUPPL-37 Labeling

Label is not available on this site.

01/05/2005 SUPPL-31 Labeling

Label is not available on this site.

12/26/2002 SUPPL-29 Labeling

Label is not available on this site.

02/19/2002 SUPPL-28 Manufacturing (CMC)-Packaging

Label is not available on this site.

12/13/2001 SUPPL-27 Manufacturing (CMC)-Packaging

Label is not available on this site.

01/04/2001 SUPPL-26 Labeling

Label is not available on this site.

12/02/1999 SUPPL-25 Manufacturing (CMC)-Facility

Label is not available on this site.

12/02/1999 SUPPL-24 Manufacturing (CMC)-Facility

Label is not available on this site.

05/26/2000 SUPPL-23 Labeling

Label is not available on this site.

05/26/2000 SUPPL-22 Manufacturing (CMC)

Label is not available on this site.

02/12/1999 SUPPL-15 Manufacturing (CMC)

Label is not available on this site.

02/12/1999 SUPPL-14 Manufacturing (CMC)

Label is not available on this site.

02/18/1998 SUPPL-13 Manufacturing (CMC)

Label is not available on this site.

10/09/1997 SUPPL-12 Manufacturing (CMC)

Label is not available on this site.

05/07/1997 SUPPL-11 Manufacturing (CMC)

Label is not available on this site.

12/11/1996 SUPPL-10 Manufacturing (CMC)

Label is not available on this site.

08/16/1996 SUPPL-9 Manufacturing (CMC)

Label is not available on this site.

04/30/1996 SUPPL-8 Manufacturing (CMC)

Label is not available on this site.

05/05/1993 SUPPL-7 Manufacturing (CMC)

Label is not available on this site.

03/04/1992 SUPPL-6 Labeling

Label is not available on this site.

04/06/1992 SUPPL-5 Manufacturing (CMC)

Label is not available on this site.

09/13/1991 SUPPL-4 Labeling

Label is not available on this site.

04/06/1992 SUPPL-3 Manufacturing (CMC)

Label is not available on this site.

06/25/1991 SUPPL-2 Manufacturing (CMC)

Label is not available on this site.

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 071196 APOTEX INC
TRAZODONE HYDROCHLORIDE TRAZODONE HYDROCHLORIDE 100MG TABLET;ORAL Prescription No AB 204852 AUROLIFE PHARMA LLC
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
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