Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 076037
Company: TEVA
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
NEFAZODONE HYDROCHLORIDE NEFAZODONE HYDROCHLORIDE 50MG TABLET;ORAL Prescription AB No No
NEFAZODONE HYDROCHLORIDE NEFAZODONE HYDROCHLORIDE 100MG TABLET;ORAL Prescription AB No No
NEFAZODONE HYDROCHLORIDE NEFAZODONE HYDROCHLORIDE 150MG TABLET;ORAL Prescription AB No No
NEFAZODONE HYDROCHLORIDE NEFAZODONE HYDROCHLORIDE 200MG TABLET;ORAL Prescription AB No No
NEFAZODONE HYDROCHLORIDE NEFAZODONE HYDROCHLORIDE 250MG TABLET;ORAL Prescription AB No Yes
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
09/16/2003 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
07/17/2014 SUPPL-11 Labeling-Package Insert Label (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/076037s011lbl.pdf
01/20/2011 SUPPL-10 Labeling-Container/Carton Labels, Labeling-Package Insert

Label is not available on this site.

01/13/2011 SUPPL-9 Labeling-Package Insert

Label is not available on this site.

10/29/2007 SUPPL-6 Labeling

Label is not available on this site.

10/29/2007 SUPPL-4 Labeling

Label is not available on this site.

10/25/2005 SUPPL-2 Labeling

Label is not available on this site.

02/18/2005 SUPPL-1 Labeling

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
07/17/2014 SUPPL-11 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/076037s011lbl.pdf

NEFAZODONE HYDROCHLORIDE

TABLET;ORAL; 50MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
NEFAZODONE HYDROCHLORIDE NEFAZODONE HYDROCHLORIDE 50MG TABLET;ORAL Prescription No AB 076037 TEVA

TABLET;ORAL; 100MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
NEFAZODONE HYDROCHLORIDE NEFAZODONE HYDROCHLORIDE 100MG TABLET;ORAL Prescription No AB 076037 TEVA

TABLET;ORAL; 150MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
NEFAZODONE HYDROCHLORIDE NEFAZODONE HYDROCHLORIDE 150MG TABLET;ORAL Prescription No AB 076037 TEVA

TABLET;ORAL; 200MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
NEFAZODONE HYDROCHLORIDE NEFAZODONE HYDROCHLORIDE 200MG TABLET;ORAL Prescription No AB 076037 TEVA

TABLET;ORAL; 250MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
NEFAZODONE HYDROCHLORIDE NEFAZODONE HYDROCHLORIDE 250MG TABLET;ORAL Prescription No AB 076037 TEVA

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