Drugs / Hydrocodone ER
Regulatory milestones approvals, filings & regulatory actions · 1 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed | US (FDA) | — | — | 2014-10-08 | “today announced the initiation of a rolling New Drug Application (NDA) submission to the U.S. Food and Drug Administration for hydrocodone bitartrate extended-release tablets” tevapharm.com ↗ |
Trials 3
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 3 | NCT01922739 | Jul 2013 → Aug 2014 | — | Teva Branded Pharmaceutical Products R&D, Inc. | Completed | No outcome recorded |
| Phase 3 | NCT01240863 | Nov 2010 → Aug 2011 | chronic pain syndrome | Teva Branded Pharmaceutical Products R&D, Inc. | Completed | No outcome recorded |
| Phase 3 | NCT01223365 | Oct 2010 → Sep 2012 | chronic pain syndrome | Teva Branded Pharmaceutical Products R&D, Inc. | Completed | No outcome recorded |
News releases announcing trial results or a regulatory action · 3
All press releases naming this drug 3 releases
| Date | Issuer | Release |
|---|---|---|
| 2015-02-25 | Teva Branded Pharmaceutical Products R&D, Inc. | Teva Announces FDA Acceptance for Review of NDA for its Investigational Twice-Daily Hydrocodone Bitartrate Extended-Release Tablets with Proprietary Abuse Deterrence Technology tevapharm.com ↗ |
| 2014-10-08 | Teva Branded Pharmaceutical Products R&D, Inc. | Teva Announces Initiation of New Drug Application and Positive Results from Second Human Abuse Liability Study for CEP-33237 (Hydrocodone Bitartrate) Extended-Release Tablets tevapharm.com ↗ |
| 2014-04-30 | Teva Branded Pharmaceutical Products R&D, Inc. | Teva Reports Positive Results from Pivotal Phase III Study to Evaluate Hydrocodone Bitartrate Extended-Release Tablets (CEP-33237) for Moderate to Severe Chronic Low Back Pain tevapharm.com ↗ |
Evidence & citations 2 cited values
Every value below carries the sentence it was read from. 3 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Hydrocodone ER | ClinicalTrials.gov intervention name — accepted as the source's own label NCT01240863 ↗ |
| Route | Oral | “Hydrocodone bitartrate extended-release tablets were administered at doses of 15, 30, 45, 60, and 90 mg orally every 12 hours.” NCT01223365 ↗ |