Complete Response Letters

International Medication Systems, Limited: Epinephrine

What FDA's Complete Response Letters to the company say, in the letters' own words.

EphemerisX Research · Sep 30, 2026 · Sources: FDA, SEC

Complete Response Letter, Dec 12, 2018

Please refer to your New Drug Application (NDA) dated and received on February 14, 2018, and your amendments, submitted pursuant to section 505(b)(2) of the Federal Food.

Complete Response Letter · Dec 12, 2018 · p. 2Open the letter at p. 2 ↗CRL_NDA211363_20181212:p1:s13

"single-dose" throughout the label and labeling.

Complete Response Letter · Dec 12, 2018 · p. 2Open the letter at p. 2 ↗CRL_NDA211363_20181212:p1:s29

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Updated Sep 30, 2026 · built from 283 companies in the EphemerisX knowledge graph. This page is regenerated as companies are added.