OXYBUTYNIN CHLORIDE | A075079 | STRIDES PHARMA INTERNATIONAL AG
| 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 | — |
Source: Regulations.gov. FDA citizen petitions matched by application number.
No patent or exclusivity listings for this strength.