| NDC Code | 0116-4005-11 |
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| Package Description | 100 CASE in 1 CASE (0116-4005-11) / 40 TRAY in 1 CASE (0116-4005-41) / 10 CUP, UNIT-DOSE in 1 TRAY / 30 mL in 1 CUP, UNIT-DOSE (0116-4005-30) |
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| Product NDC | 0116-4005 |
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| Product Type Name | HUMAN PRESCRIPTION DRUG |
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| Proprietary Name | Lactulose |
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| Non-Proprietary Name | Lactulose |
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| Dosage Form | SOLUTION |
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| Usage | ORAL |
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| Start Marketing Date | 20220701 |
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| Marketing Category Name | ANDA |
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| Application Number | ANDA075911 |
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| Manufacturer | Xttrium Laboratories, Inc. |
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| Substance Name | LACTULOSE |
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| Strength | 10 |
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| Strength Unit | g/15mL |
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| Pharmacy Classes | Acidifying Activity [MoA], Osmotic Activity [MoA], Osmotic Laxative [EPC], Stimulation Large Intestine Fluid/Electrolyte Secretion [PE] |
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