| NDC Code | 64380-116-01 |
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| Package Description | 2 BOTTLE in 1 CARTON (64380-116-01) / 177 mL in 1 BOTTLE (64380-116-02) |
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| Product NDC | 64380-116 |
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| Product Type Name | HUMAN PRESCRIPTION DRUG |
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| Proprietary Name | Sodium Sulfate, Potassium Sulfate And Magnesium Sulfate Oral |
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| Non-Proprietary Name | Sodium Sulfate, Potassium Sulfate And Magnesium Sulfate Oral |
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| Dosage Form | SOLUTION |
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| Usage | ORAL |
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| Start Marketing Date | 20240117 |
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| Marketing Category Name | ANDA |
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| Application Number | ANDA215469 |
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| Manufacturer | Strides Pharma Science Limited |
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| Substance Name | MAGNESIUM SULFATE, UNSPECIFIED FORM; POTASSIUM SULFATE; SODIUM SULFATE |
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| Strength | 1.6; 3.13; 17.5 |
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| Strength Unit | g/177mL; g/177mL; g/177mL |
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| Pharmacy Classes | Calculi Dissolution Agent [EPC], Increased Large Intestinal Motility [PE], Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Small Intestine Fluid/Electrolyte Absorption [PE], Magnesium Ion Exchange Activity [MoA], Osmotic Activity [MoA], Osmotic Activity [MoA], Osmotic Laxative [EPC], Osmotic Laxative [EPC], Stimulation Large Intestine Fluid/Electrolyte Secretion [PE] |
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