VOLTAREN-XR

FDA-2025-P-4911 · 10 docket documents

Laboflex Inc. filed an amendment to its ANDA suitability petition for Diclofenac Sodium Plaster, 1%, addressing the FDA's concerns regarding discrepancies between the proposed labeling and the reference listed drug regarding frequency of administration and maximum plaster usage, and submitted revise

FDA-2020-P-1393 · 3 docket documents

Nexus Pharmaceuticals Inc filed this suitability petition under section 505(j)(2)(C) requesting FDA approval to submit an ANDA or Prior Approval Supplement for Levetiracetam in Sodium Chloride injection at an intermediate 750 mg/100 mL strength, which differs from the reference listed drug NDA 20254

FDA-2018-P-2901 · 4 docket documents

Yiling Pharmaceutical Ltd filed this citizen petition under 21 CFR 10.25(a) and 10.30 requesting that the FDA select a different listed drug as the reference standard for VOLTAREN diclofenac sodium delayed-release tablets in 75mg, 50mg, and 25mg strengths to be used in conducting in vivo bioequivale

FDA-2018-P-1263 · 6 docket documents

Kratz & Barry LLP, on behalf of Rubicon Research Private Limited, filed a citizen petition under Section 505(j) of the Federal Food, Drug and Cosmetic Act requesting that the FDA designate Diclofenac Sodium delayed release tablets in 25 mg and 50 mg strengths held by Unique Pharmaceutical Laboratori

FDA-2007-P-0348 · 7 docket documents

King & Spalding LLP filed a suitability petition under Section 505(j)(2)(C) requesting that the FDA declare a new enteric-coated capsule dosage form containing diclofenac sodium and misoprostol in 50 mg/200 mcg and 75 mg/200 mcg combinations suitable for submission via ANDA, with the reference liste