Drugs / Carboprost Tromethamine
Regulatory milestones approvals, filings & regulatory actions · 1 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Approved | US (FDA) | HEMABATE | — | 1979-01-09 | fda.gov ↗ |
Trials 2
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 01 trial | ||||||
| Phase 0 | NCT05518812 | Jul 2022 → May 2024 | female reproductive system disorder, leiomyoma | Northwestern University | Completed | No outcome recorded |
| Phase 41 trial | ||||||
| Phase 4 | NCT01549223 | Apr 2011 → Jan 2012 | hypotensive disorder, uterine disorder | Brigham and Women's Hospital | Completed | No outcome recorded |
| Comparator or background therapy1 trial | ||||||
| — | NCT02861482 Background | Jan 2015 → Mar 2016 | — | Dongyu Wang | Completed | No outcome recorded |
News releases announcing trial results or a regulatory action · 2
| Date | Issuer | Release |
|---|---|---|
| 2023-07-01 | Alembic Pharmaceuticals Ltd. | Regulatory APL-PR-USFDA-Products-Approval-Qtr-Ended-30062023.pdf alembicpharmaceuticals.com ↗ |
| 2022-02-17 | Impax Laboratories, LLC | Regulatory Amneal Expands Injectables Portfolio with 4 New Products amneal.com ↗
Dexamethasone sodium phosphate injection, USP 10 mg/mL, azacitidine 100 mg, carboprost tromethamine injection, USP 250 mcg/mL, and atropine sulfate injection, USP 0.5 mg/5 mL, have received Abbreviated New Drug Application (ANDA) approval from the U.S. Food and Drug Administration (FDA). |
All press releases naming this drug 2 releases
| Date | Issuer | Release |
|---|---|---|
| 2023-07-01 | Alembic Pharmaceuticals Ltd. | APL-PR-USFDA-Products-Approval-Qtr-Ended-30062023.pdf alembicpharmaceuticals.com ↗ |
| 2022-02-17 | Impax Laboratories, LLC | Amneal Expands Injectables Portfolio with 4 New Products amneal.com ↗ |
Evidence & citations 3 cited values
Every value below carries the sentence it was read from. 3 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | carboprost tromethamine | “carboprost tromethamine (hemabate) 0.25 mg IM” NCT01549223 ↗ |
| Known as | hemabate | “carboprost tromethamine (hemabate) 0.25 mg IM” NCT01549223 ↗ |
| Route | Intramuscular | “carboprost tromethamine (hemabate) 0.25 mg IM” NCT01549223 ↗ |