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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 076037
Company: TEVA

Other Important Information from FDA

Products on ANDA 076037

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
NEFAZODONE HYDROCHLORIDE	NEFAZODONE HYDROCHLORIDE	50MG	TABLET;ORAL	Prescription	None	No	No
NEFAZODONE HYDROCHLORIDE	NEFAZODONE HYDROCHLORIDE	100MG	TABLET;ORAL	Prescription	None	No	No
NEFAZODONE HYDROCHLORIDE	NEFAZODONE HYDROCHLORIDE	150MG	TABLET;ORAL	Prescription	None	No	No
NEFAZODONE HYDROCHLORIDE	NEFAZODONE HYDROCHLORIDE	200MG	TABLET;ORAL	Prescription	None	No	No
NEFAZODONE HYDROCHLORIDE	NEFAZODONE HYDROCHLORIDE	250MG	TABLET;ORAL	Prescription	None	No	Yes

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 076037

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
06/24/2025	SUPPL-18	Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.
06/16/2025	SUPPL-17	Labeling-Package Insert, Labeling-Container/Carton Labels, Labeling-Medication Guide		Label is not available on this site.
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-Package Insert, Labeling-Container/Carton Labels		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.

Labels for ANDA 076037

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

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