| NDC Code | 0121-0833-00 |
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| Package Description | 10 TRAY in 1 CASE (0121-0833-00) / 10 CUP, UNIT-DOSE in 1 TRAY / 5 mL in 1 CUP, UNIT-DOSE (0121-0833-05) |
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| Product NDC | 0121-0833 |
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| Product Type Name | HUMAN OTC DRUG |
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| Proprietary Name | Childrens Ibuprofen Oral Suspension |
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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 | 20250801 |
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| Marketing Category Name | ANDA |
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| Application Number | ANDA214789 |
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| Manufacturer | PAI Holdings, LLC dba PAI Pharma |
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| Substance Name | IBUPROFEN |
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| Strength | 100 |
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| Strength Unit | mg/5mL |
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| Pharmacy Classes | Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC] |
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