Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 207975
Company: TEVA BRANDED PHARM
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 |