Drugs / carbidopa/levodopa
Trials 1
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 1 | NCT02812394 | Jun → Aug 2016 | Parkinson disease | Acorda Therapeutics | Completed | No outcome recorded |
News releases announcing trial results or a regulatory action · 1
| Date | Issuer | Release |
|---|---|---|
| 2004-05-17 | Impax Laboratories, LLC | Regulatory IMPAX Receives Final FDA Approval for Generic Version of Sinemet CR; Sixth ANDA Approval in 2004 amneal.com ↗
HAYWARD, Calif.--(BUSINESS WIRE)--May 17, 2004--IMPAX Laboratories, Inc. (Nasdaq:IPXL) today announced that the U.S. Food and Drug Administration (FDA) has granted final approval to the Company's Abbreviated New Drug Application (ANDA) for Carbidopa/Levodopa Extended Release Tablets, its generic version of Sinemet(R) CR tablets. |
All press releases naming this drug 1 release
| Date | Issuer | Release |
|---|---|---|
| 2004-05-17 | Impax Laboratories, LLC | IMPAX Receives Final FDA Approval for Generic Version of Sinemet CR; Sixth ANDA Approval in 2004 amneal.com ↗ |
Evidence & citations 3 cited values
Every value below carries the sentence it was read from. 1 source stands behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | carbidopa/levodopa | “Sinemet® (carbidopa/levodopa) tablets” NCT02812394 ↗ |
| Known as | Sinemet | “A Study to Compare Two Dose Strengths of CVT-301 (Levodopa Inhalation Powder) With an Oral Dose of Sinemet® (Carbidopa-levodopa) Tablets” NCT02812394 ↗ |
| Route | Oral | “orally administered carbidopa/levodopa” NCT02812394 ↗ |