Roxatidine acetate
- Generic Name
- Roxatidine acetate
- Drug Type
- Small Molecule
- Chemical Formula
- C19H28N2O4
- CAS Number
- 78628-28-1
- Unique Ingredient Identifier
- ZUP3LSD0DO
Overview
Roxatidine acetate is a specific and competitive H2 receptor antagonist. It is currently approved in South Africa under the tradename Roxit.
Background
Roxatidine acetate is a specific and competitive H2 receptor antagonist. It is currently approved in South Africa under the tradename Roxit.
Indication
For the treatment of disorders of the upper gastro-intestinal region that are due to an excess of hydrochloric acid in the gastric juice, i.e. duodenal ulcers, benign gastric ulcers. Also for prophylaxis of recurrent gastric and duodenal ulcers
Associated Conditions
No associated conditions information available.
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
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No clinical trials found
No clinical trials found for this drug
FDA Approved Products
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No FDA products found
No FDA products found for this drug
EMA Approved Products
Medicine Name | EMA Number | Auth. Holder | Country | Drug Type | Status | Issued | Opinion | Revision |
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No EMA products found
No EMA products found for this drug
HSA Approved Products
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No HSA products found
No HSA products found for this drug
NMPA Approved Products
Product Name | Approval No. | Manufacturer | Dosage Form | Trade Name | Strength | Type | Status | Date | Import |
|---|---|---|---|---|---|---|---|---|---|
国药准字H20249238 | 注射剂 | N/A | 75mg | Chemical Drug | Approved | 2024/10/29 | Domestic | ||
国药准字H20253570 | 注射剂 | N/A | 75mg | Chemical Drug | Approved | 2025/03/11 | Domestic | ||
国药准字H20254006 | 注射剂 | N/A | 75mg | Chemical Drug | Approved | 2025/04/22 | Domestic | ||
国药准字H20254002 | 注射剂 | N/A | 75mg | Chemical Drug | Approved | 2025/04/22 | Domestic | ||
国药准字H20254022 | 注射剂 | N/A | 75mg | Chemical Drug | Approved | 2025/04/30 | Domestic | ||
国药准字H20253155 | 注射剂 | N/A | 75mg | Chemical Drug | Approved | 2025/01/14 | Domestic | ||
国药准字H20233779 | 注射剂 | N/A | 75mg（按C₁₉H₂₈N₂O₄•HCl计） | Chemical Drug | Approved | 2023/06/27 | Domestic | ||
国药准字H20243662 | 注射剂 | N/A | 75mg | Chemical Drug | Approved | 2024/05/08 | Domestic | ||
国药准字H20140084 | 注射剂 | N/A | 75mg | Chemical Drug | Approved | 2024/07/30 | Domestic | ||
国药准字H20120076 | 注射剂(冻干粉针剂) | N/A | 75mg | Chemical Drug | Approved | 2022/08/12 | Domestic |
PPB Approved Products
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No PPB products found
No PPB products found for this drug
TGA Approved Products
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No TGA products found
No TGA products found for this drug