PHENYLEPHRINE HYDROCHLORIDE

FDA-2026-P-6257 · 8 docket documents

Apotex Corp. filed a suitability petition requesting that the FDA determine whether orlistat is a suitable candidate for abbreviated new drug application (ANDA) approval as a generic version of Xenical.

FDA-2018-P-1008 · 5 docket documents

VPCI, Inc. filed a suitability petition under Section 505(j)(2)(C) of the Food, Drug and Cosmetic Act requesting permission to submit an Abbreviated New Drug Application for phenylephrine hydrochloride injection at a concentration of 0.1 mg/mL, which differs from the Reference Listed Drug VAZCULEP (

FDA-2015-P-4131 · 6 docket documents

The University of Florida filed this citizen petition under 21 CFR Part 10.30 requesting that the FDA issue a final rule removing oral phenylephrine (both phenylephrine hydrochloride and phenylephrine bitartrate) from the Final Monograph for OTC nasal decongestant drug products, arguing that subsequ

FDA-2014-P-0311 · 3 docket documents

Sheppard, Mullin, Richter & Hampton LLP filed this ANDA suitability petition under Section 505(j)(2)(C) requesting that the FDA declare Phenylephrine Hydrochloride Injection, USP, 10 mg/mL in a 5 mL glass vial suitable for submission in an ANDA, with the reference listed drug being West-Ward Pharmac

FDA-2006-P-0395 · 7 docket documents

Strides Inc. filed this citizen petition under Section 505(j)(2)(C) of the Federal Food, Drug, and Cosmetic Act requesting FDA approval to file an Abbreviated New Drug Application for Ibuprofen Potassium 200 mg Phenylephrine Hydrochloride 10 mg Capsules, which substitutes phenylephrine hydrochloride