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Registersublingual tablets [Regulatives / Guidelines]
Dear Mr Amr Hussein,
Even FDA recommends to do Bioequivalence study for ANDA submission of Isosorbide dinitrate sublingual tablets.
Reference: FDA Docket No. 77N-0240; DESI 1786
❝ The necessity to do bioequivalence study for sublingual tablets especially isosorbid dinitrate 5mg tablets as it is totally absorbed from oromucosal cavity
Even FDA recommends to do Bioequivalence study for ANDA submission of Isosorbide dinitrate sublingual tablets.
Reference: FDA Docket No. 77N-0240; DESI 1786
—
Dr Gunasakaran Sambandan MD
Disclaimer: The replies/posts are my personal opinions, and they do not represent my company's views on the same. LinkedIn
Dr Gunasakaran Sambandan MD
Disclaimer: The replies/posts are my personal opinions, and they do not represent my company's views on the same. LinkedIn
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