NAPROSYN

FDA-2021-P-0340

Drug Device Consulting LLC filed a citizen petition regarding the suitability of the reference listed drug (RLD) label for Naproxen Suspension 25 mg/mL. The petition appears to challenge or question the appropriateness of the existing RLD labeling for this naproxen suspension formulation.

FDA-2021-P-0340

Drug Device Consulting LLC filed this suitability petition under section 502(j)(2)(C) of the FD&C Act requesting FDA approval to submit an ANDA for Naproxen Suspension at a new 50mg/mL strength, which would be an additional strength to the already-approved 25mg/mL reference listed drug Naprosyn, all

FDA-2021-P-0340

Drug Device Consulting LLC filed a citizen petition requesting that the FDA determine the suitability of a draft label for naproxen suspension 50 mg/mL formulation. The petition seeks FDA review and approval of the proposed labeling for this over-the-counter or prescription naproxen suspension produ

FDA-2017-P-6689

Novitium Pharma LLC, a specialty pharmaceutical company developing generic drugs, submitted a citizen petition pursuant to 21 CFR 10.25(a), 10.30, and 314.122 requesting that the FDA designate West Ward Pharmaceuticals International Limited's approved generic Naproxen Oral Suspension 25 mg/mL (ANDA