Drugs / Benzonatate
Benzonatate
Regulatory milestones approvals, filings & regulatory actions · 2 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed cough variant asthma 1 milestone | |||||
| Filed | US (FDA) | — | cough variant asthma | 2014-12-17 | “Benzonatate Soft Capsule is one of the Group’s products with Abbreviated New Drug Application submitted to U.S.” irasia.com ↗ |
| Approved Indication not stated 1 milestone | |||||
| Approved | US (FDA) | TESSALON | — | 1958-02-10 | fda.gov ↗ |
Trials 3
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| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 13 trials | ||||||
| Phase 1 | NCT03922373 | Sep 2018 → Feb 2019 | — | CSPC ZhongQi Pharmaceutical Technology Co., Ltd. | Unknown | No outcome recorded |
| Phase 1 | NCT02207699 | May → Jul 2014 | — | Pfizer | Completed | No outcome recorded |
| Phase 1 | NCT01690975 | Jul → Aug 2012 | — | Pfizer | Completed | No outcome recorded |
| Comparator or background therapy1 trial | ||||||
| Phase 3 | NCT03722914 Comparator | Mar → Dec 2018 | — | CSPC ZhongQi Pharmaceutical Technology Co., Ltd. | Unknown | No outcome recorded |
News releases announcing trial results or a regulatory action · 2
| Date | Issuer | Release |
|---|---|---|
| 2015-08-05 | CSPC ZhongQi Pharmaceutical Technology Co., Ltd. | Regulatory VOLUNTARY ANNOUNCEMENT - THE GROUP'S COUGH SUPPRESSANT PRODUCT "BENZONATATE SOFT CAPSULE" WAS GRANTED DRUG REGISTRATION APPROVAL BY THE U.S. FDA irasia.com ↗
The board of directors (the “ Board”) of CSPC Pharmaceutical Group Limited (the “ Company”, together with its subsidiaries (the “ Group”)) announces that the Group’s product “Benzonatate Soft Capsule” has passed the Abbreviated New Drug Application ( “ANDA”) (File no.: 202765) and was granted drug registration approval by the U.S. Food and Drug Administration (“U.S. FDA”). |
| 2014-12-17 | CSPC ZhongQi Pharmaceutical Technology Co., Ltd. | Regulatory Voluntary Announcement - The Group's production workshop for cough suppressant product "Benzonatate Soft Capsule" passed onsite inspection by the U.S.FDA irasia.com ↗ |
All press releases naming this drug 3 releases
| Date | Issuer | Release |
|---|---|---|
| 2015-08-05 | CSPC ZhongQi Pharmaceutical Technology Co., Ltd. | VOLUNTARY ANNOUNCEMENT - THE GROUP'S COUGH SUPPRESSANT PRODUCT "BENZONATATE SOFT CAPSULE" WAS GRANTED DRUG REGISTRATION APPROVAL BY THE U.S. FDA irasia.com ↗ |
| 2014-12-17 | CSPC ZhongQi Pharmaceutical Technology Co., Ltd. | Voluntary Announcement - The Group's production workshop for cough suppressant product "Benzonatate Soft Capsule" passed onsite inspection by the U.S.FDA irasia.com ↗ |
| 2008-03-21 | Sun Pharmaceutical Industries, Inc. | Sun Pharmaceutical announces USFDA approval to market generic Tessalon ® sunpharma.com ↗ |
Evidence & citations 7 cited values
Every value below carries the sentence it was read from. 5 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Benzonatate | ClinicalTrials.gov intervention name — accepted as the source's own label NCT03722914 ↗ |
| Known as | Benzonatato | ChEMBL registry synonym — accepted as the source's own label CHEMBL1374379 ↗ |
| Known as | NSC-760128 | ChEMBL registry synonym — accepted as the source's own label CHEMBL1374379 ↗ |
| Known as | Tessalon | ChEMBL registry synonym — accepted as the source's own label CHEMBL1374379 ↗ |
| Known as | Tessalon perles | ChEMBL registry synonym — accepted as the source's own label CHEMBL1374379 ↗ |
| Modality | Small molecule | — CHEMBL1374379 ↗ |
| Route | Oral | “increasing oral doses of benzonatate” NCT01690975 ↗ |