Drugs@FDA: FDA Approved Drug Products

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

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