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Thus prompted by encouragement from FDA the sponsor developed this new phthalate-free formulation of WC3045 capsule in which dibutyl phthalate has been replaced with an alternate plasticizer dibutyl sebacate. Please forward written response as soon as you receive to Dr. Sam Haidar and POC Fax 1-301-847-8748 or Email sam.haidar fda.hhs. REGULATORY HISTORY is a revised formulation of Delayed Release Tablets NDA 019651. The sponsor submitted an NDA for WC3045 delayed release 400 mg capsules on...
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