Potassium bicarbonate is a white, crystalline, slightly alkaline and salty substance. It is produced by the passage of carbon dioxide through an aqueous potassium carbonate solution. It is used in medicine as an antacid. It is registered in the FDA under the section of suitable, safe and effective ingredients for OTC antacids. This FDA denomination classifies potassium bicarbonate as a GRAS ingredient.
Potassium bicarbonate is a white, crystalline, slightly alkaline and salty substance. It is produced by the passage of carbon dioxide through an aqueous potassium carbonate solution. It is used in medicine as an antacid. It is registered in the FDA under the section of suitable, safe and effective ingredients for OTC antacids. This FDA denomination classifies potassium bicarbonate as a GRAS ingredient.
Potassium bicarbonate is used as an antacid, electrolyte replenisher and potassium supplement. It can also be used as an excipient in drug formulations. An antacid is a medication used to neutralize gastric acid in a short timeframe after ingestion and the effect is soon overcome by meal-stimulated acid secretion.
Title | Posted | Study ID | Phase | Status | Sponsor |
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2020/12/03 | Early Phase 1 | Not yet recruiting |
Product Name | Manufacturer | Route | Strength | Approved | NDC Code |
---|---|---|---|---|---|
ORAL | 391 mg in 1 1 | 2019/12/19 | 51801-013 | ||
ORAL | 782 mg in 1 1 | 2019/12/19 | 51801-012 | ||
ORAL | 391 mg in 1 1 | 2019/12/19 | 51801-014 | ||
ORAL | 25 meq in 1 1 | 2010/10/08 | 50201-2400 | ||
ORAL | 782 mg in 1 1 | 2019/12/19 | 51801-011 | ||
ORAL | 25 meq in 1 1 | 2012/04/20 | 0603-4170 | ||
ORAL | 978 mg in 1 1 | 2020/06/30 | 0245-5326 | ||
ORAL | 977.5 mg in 1 1 | 2019/12/23 | 51801-006 | ||
ORAL | 977.5 mg in 1 1 | 2019/12/23 | 51801-007 | ||
ORAL | 977.5 mg in 1 1 | 2019/12/23 | 51801-005 |
Medicine Name | EMA Number | Auth. Holder | Country | Drug Type | Status | Issued | Opinion | Revision |
---|---|---|---|---|---|---|---|---|
EMEA/H/C/005407 | France | N/A | Authorised | 2021/04/30 | 2020/12/10 | 3 |
Product Name | Manufacturer | Dosage Form | Strength | Approved | Approval No. |
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SUSPENSION | 200 MG/10ML | 2020/11/17 | SIN16042P | ||
SUSPENSION | 200 mg/10 ml | 2004/12/24 | SIN12635P |
Product Name | Approval No. | Manufacturer | Dosage Form | Trade Name | Strength | Type | Status | Date | Import |
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No NMPA products found for this drug
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No PPB products found for this drug
Product Name | ARTG ID | Sponsor | Status | Reg. Date | Ingredient |
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71981 | Active | 1999/12/01 | potassium bicarbonate | ||
77810 | Active | 2001/03/13 | potassium bicarbonate | ||
346341 | Active | 2020/10/21 | potassium bicarbonate |