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Fda Guidance 824

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Preview of Approval of Supplemental New Drug Applications for Motrin IB and Children's Motrin
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Approval of Supplemental New Drug Applications for Motrin IB and Children's Motrin (19012slr03420516slr011ltr.pdf)

92 KBWalter J. EllenbergEN 4 pages
Please refer to supplemental drug applications for Motrin IB (200 mg ibuprofen) caplets (NDA 19-012/S-034) and Children’s Motrin (100 mg ibuprofen /5 ml) oral suspension (NDA 20-516/S-011).
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