OXYBUTYNIN CHLORIDE | N020897 | JANSSEN PHARMACEUTICALS INC
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Citizen Petition from Foley & Lardner LLP FDA-2019-P-4507 · 3 docket documents Foley & Lardner LLP filed a citizen petition under Section 505(j) requesting that the FDA designate the Accord Healthcare Inc. ANDA for Oxybutynin Chloride Extended Release Tablets 15 mg as an additional reference standard because the original reference listed drug, DITROPAN XL, is discontinued and | Other | 2019-09-26 | Withdrawn | Foley & Lardner LLP |
Citizen Petition from Ajanta Pharma USA Inc. FDA-2018-P-1361 · 4 docket documents Ajanta Pharma Limited filed this petition on April 2, 2018, requesting that the FDA determine whether Ditropan XL (Oxybutynin Chloride) Extended Release Tablets in 5 mg, 10 mg, and 15 mg strengths, approved under NDA 020897 and held by Janssen Pharmaceuticals Inc., was voluntarily withdrawn from the | 505(q) | 2018-04-02 | Denied | Ajanta Pharma USA Inc. |
Citizen Petition form Hyman, Phelps & McNamara, P.C. FDA-2018-P-1335 · 4 docket documents Hyman, Phelps & McNamara, P.C. filed this citizen petition under 21 C.F.R. §§ 10.25 and 10.30 and pursuant to Sections 505(j) and 505(w) of the Federal Food, Drug, and Cosmetic Act requesting that FDA determine whether DITROPAN XL (Oxybutynin Chloride) Extended Release Tablets in 5 mg, 10 mg, and 15 | 505(q) | 2018-03-30 | Partially Denied | — |
Source: Regulations.gov. FDA citizen petitions matched by application number.
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