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Schering-Plough's Nitro-Dur transdermal nitroglycerin patch has full FDA approval.

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Executive Summary

SCHERING-PLOUGH NITRO-DUR NITRO PATCH SUPPLEMENTAL NDAs APPROVED by FDA on April 4, making the nitroglycerin transdermal infusion system the first pre-1962 nitroglycerin product in a patch form to have fully approved NDAs. FDA asked manufacturers of nitro patches to submit NDAs for the DESI drugs in a Federal Register notice of July 15, 1993 ("The Pink Sheet" July 19, 1993, T&G-2). Nitro-Dur and Ciba/Summit's Transderm-Nitro were then deemed the "reference drugs."

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This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

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