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FDA approval · 2012-03-05

FDA Approved: IBUPROFEN PM — Original Application (TOP CARE (Topco Associates LLC))

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Summary

FDA approved Ibuprofen PM from Top Care (Topco Associates LLC) as an original ANDA, a nighttime analgesic combining ibuprofen with diphenhydramine HCl.

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Diseases / indications

Drugs mentioned

  • IBUPROFEN PM (ibuprofen; diphenhydramine hydrochloride)

Snippet

ORIG AP for IBUPROFEN PM (IBUPROFEN, DIPHENHYDRAMINE HCL)