| NDC Code | 0121-2044-00 |
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| Package Description | 10 CUP, UNIT-DOSE in 1 CASE (0121-2044-00) / 10 mL in 1 CUP, UNIT-DOSE |
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| Product NDC | 0121-2044 |
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| Product Type Name | HUMAN OTC DRUG |
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| Proprietary Name | Dye Free Childrens Ibuprofen |
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| Non-Proprietary Name | Ibuprofen |
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| Dosage Form | SUSPENSION |
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| Usage | ORAL |
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| Start Marketing Date | 20231103 |
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| Marketing Category Name | ANDA |
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| Application Number | ANDA210602 |
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| Manufacturer | PAI Holdings, LLC dba PAI Pharma |
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| Substance Name | IBUPROFEN |
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| Strength | 200 |
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| Strength Unit | mg/10mL |
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| Pharmacy Classes | Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC] |
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