Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

New Drug Application (NDA): 207975
Company: TEVA BRANDED PHARM

• Medication Guide

• FDA has determined that this product has abuse-deterrent properties

• REMS

Products on NDA 207975

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
VANTRELA ER	HYDROCODONE BITARTRATE	15MG	TABLET, EXTENDED RELEASE;ORAL	Discontinued	None	Yes	No
VANTRELA ER	HYDROCODONE BITARTRATE	30MG	TABLET, EXTENDED RELEASE;ORAL	Discontinued	None	Yes	No
VANTRELA ER	HYDROCODONE BITARTRATE	45MG	TABLET, EXTENDED RELEASE;ORAL	Discontinued	None	Yes	No
VANTRELA ER	HYDROCODONE BITARTRATE	60MG	TABLET, EXTENDED RELEASE;ORAL	Discontinued	None	Yes	No
VANTRELA ER	HYDROCODONE BITARTRATE	90MG	TABLET, EXTENDED RELEASE;ORAL	Discontinued	None	Yes	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 207975

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
01/17/2017	ORIG-1	Approval	Type 3 - New Dosage Form	STANDARD	Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/207975s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/207975Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2017/207975Orig1s000TOC.cfm

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
05/26/2017	SUPPL-2	REMS-Modified	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/207975Orig1s002ltr.pdf

Labels for NDA 207975

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
01/17/2017	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/207975s000lbl.pdf