Complete Response Letters
Glenmark Pharmaceuticals, Inc.: GSP
What FDA's Complete Response Letters to the company say, in the letters' own words.
Complete Response Letter, Jun 20, 2019
Please refer to your new drug application (NDA) dated and received May 21, 2018 and your amendments, submitted pursuant to section 505(b)(2) of the Federal Food, Drug, and Cosmetic Act for GSP 301 (olopatadine HCI and mometasone furoate) 665 mcg/25 mcg Nasal Spray.
CRL_NDA211746_20190620:p1:s10We acknowledge receipt of your major amendment dated January 31, 2019, which extended the goal date by three months.
CRL_NDA211746_20190620:p1:s11More Complete Response Letters
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