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In the November 16, 2015, Federal Register, FDA announced that all outstanding hearing requests regarding nitroglycerin drug products in transdermal systems under Docket No. FDA-1977-N-0356 (DESI 1786) have been withdrawn.
United StatesFood, Drugs, Healthcare, Life Sciences
In the November 16, 2015, Federal Register, FDA announced that all
outstanding hearing requests regarding nitroglycerin drug products
in transdermal systems under Docket No. FDA-1977-N-0356 (formerly 77N-0240)
(DESI 1786) have been withdrawn. Accordingly, shipment in
interstate commerce of any nitroglycerin drug product in a
transdermal system identified in this docket, or any identical,
related, or similar product, that is not the subject of an approved
new drug application or abbreviated new drug application is
unlawful as of the effective date of the notice.
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