Drugs / CEFPROZIL ANHYDROUS, (E)-
CEFPROZIL ANHYDROUS, (E)-
also known as
Cefprozil · Cefzil · Cefprozil monohydrate · CEFPROZIL, (E)- · Cefprozil, (e)-isomer · Cefprozilo · NSC-759099
Regulatory milestones approvals, filings & regulatory actions · 4 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Label expansions (3) | US (FDA) | CEFZIL | — | 1992-12-31 – 1996-09-05 | fda.gov ↗ |
| Approved | US (FDA) | CEFZIL | — | 1991-12-23 | fda.gov ↗ |
Trials 9
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 18 trials · 3 met primary | ||||||
| Phase 1 | NCT00881400 | Jun 2004 | — | Sandoz | Completed | No outcome recorded |
| Phase 1 | NCT00835354 | May 2004 | — | Teva Pharmaceuticals USA | Completed | Met primary |
| Phase 1 | NCT00881153 | May → Jun 2004 | — | Sandoz | Completed | No outcome recorded |
| Phase 1 | NCT00835614 | Apr 2004 | — | Teva Pharmaceuticals USA | Completed | No outcome recorded |
| Phase 1 | NCT00881426 | Mar → Apr 2004 | — | Sandoz | Completed | No outcome recorded |
| Phase 1 | NCT00881855 | Mar → Apr 2004 | — | Sandoz | Completed | No outcome recorded |
| Phase 1 | NCT00840281 | Sep 2003 | — | Teva Pharmaceuticals USA | Completed | Met primary |
| Phase 1 | NCT00840866 | Sep 2003 | — | Teva Pharmaceuticals USA | Completed | Met primary |
| Phase 41 trial | ||||||
| Phase 4 | NCT06494072 | Aug 2024 → May 2028 expected | — | Medical College of Wisconsin | Recruiting | No outcome recorded |
| Comparator or background therapy1 trial | ||||||
| Phase 0 | NCT02099240 Comparator | Mar 2014 → Nov 2018 | osteomyelitis | University of Louisville | Terminated | No outcome recorded Stop: Enrollment |
News releases announcing trial results or a regulatory action · 1
| Date | Issuer | Release |
|---|---|---|
| 2005-12-09 | Teva Branded Pharmaceutical Products R&D, Inc. | Regulatory Teva Announces Approval of Cefprozil Tablets and Cefprozil for Oral Suspension Usp tevapharm.com ↗ |
All press releases naming this drug 2 releases
| Date | Issuer | Release |
|---|---|---|
| 2013-02-13 | Sobi, Inc. | Sobi gains distribution rights for Megace®, Monopril®, Cefzil® and Duricef® from PharmaSwiss sobi.com ↗ |
| 2005-12-09 | Teva Branded Pharmaceutical Products R&D, Inc. | Teva Announces Approval of Cefprozil Tablets and Cefprozil for Oral Suspension Usp tevapharm.com ↗ |
Evidence & citations 10 cited values
Every value below carries the sentence it was read from. 11 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | CEFPROZIL ANHYDROUS, (E)- | ChEMBL registry synonym — accepted as the source's own label CHEMBL276568 ↗ |
| Known as | Cefprozil | “Cefprozil” NCT02099240 ↗ |
| Known as | Cefprozil monohydrate | ChEMBL registry synonym — accepted as the source's own label CHEMBL276568 ↗ |
| Known as | CEFPROZIL, (E)- | ChEMBL registry synonym — accepted as the source's own label CHEMBL276568 ↗ |
| Known as | Cefprozil, (e)-isomer | ChEMBL registry synonym — accepted as the source's own label CHEMBL276568 ↗ |
| Known as | Cefprozilo | ChEMBL registry synonym — accepted as the source's own label CHEMBL276568 ↗ |
| Known as | Cefzil | “The objective of this study is to compare the relative bioavailability of cefprozil for oral suspension 250 mg/5 mL (TEVA Pharmaceuticals USA) with that of CEFZIL® for Oral...” NCT00835354 ↗5“Cefzil (Cefprozil) 250 mg/5 ml Oral Suspension (Bristol-Myers Squibb, USA)” NCT00881400 ↗ “Cefzil (Cefprozil) 250 mg/5 ml Oral Suspension (Bristol-Myers Squibb)” NCT00881153 ↗ “Cefzil (Cefprozil) 500 mg Tablets (Bristol-Myers Squibb, USA)” NCT00881855 ↗ “Cefzil (Cefprozil) 500 mg Tablets (Bristol-Myers Squibb)” NCT00881426 ↗ “Drug: Cefzil®” NCT00840866 ↗ |
| Known as | NSC-759099 | ChEMBL registry synonym — accepted as the source's own label CHEMBL276568 ↗ |
| Modality | Small molecule | — CHEMBL276568 ↗ |
| Route | Oral | “Cefprozil for oral suspension 250 mg/5 mL” NCT00835354 ↗ |