OXYBUTYNIN CHLORIDE | N020897 | JANSSEN PHARMACEUTICALS INC
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Amendment to Suitability Petition for Oxybutynin Chloride Tablets, USP 2.5 mg FDA-2016-P-1088 ABHAI, LLC filed an amendment to a suitability petition under 21 CFR 314.93 requesting FDA approval to submit an ANDA for Oxybutynin Chloride Tablets in a 2.5 mg strength, an additional strength to the approved 5 mg strength referenced to Janssen Pharmaceuticals' NDA 017577. The petitioner argues cl | Suitability | 2020-10-05 | Open | — |
Citizen Petition from Ajanta Pharma USA Inc. FDA-2018-P-1361 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5 mg, 10 mg, and 15 mg strengths, approved under NDA 020897 and held by Janssen Pharmaceuticals Inc., was voluntarily withdrawn from the | 505(q) | 2018-04-02 | Withdrawn | Ajanta Pharma USA Inc. |
Source: Regulations.gov. FDA citizen petitions matched by application number.
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