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 | Granted | — |
Citizen Petition from ABHAI LLC c/o KVK-Tech, Inc FDA-2016-P-1088 ABHAI LLC filed a suitability petition under 21 CFR section 314.93 requesting FDA approval to submit an ANDA for Oxybutynin Chloride Tablets in a 2.5 mg strength, which would be an additional strength to the already-approved 5 mg strength referenced in ANDA 075079. The petitioner argues that the 2.5 | Other | 2016-03-29 | Granted | ABHAI LLC c/o KVK-Tech, Inc |
Source: Regulations.gov. FDA citizen petitions matched by application number.
Highest NADAC/Unit
$0.0488
per ea
Lowest NADAC/Unit
$0.0488
per ea
Brand NDCs
0
Generic NDCs
3
| NDC Description | NADAC/Unit | Unit | Type | Generic NADAC | Effective |
|---|---|---|---|---|---|
| 64380016201OXYBUTYNIN 5 MG TABLET | $0.0488 | EA | Generic | — | 2026-10-21 |
| 64380016202OXYBUTYNIN 5 MG TABLET | $0.0488 | EA | Generic | — | 2026-10-21 |
| 64380016203OXYBUTYNIN 5 MG TABLET | $0.0488 | EA | Generic | — | 2026-10-21 |
Source: NADAC (data.medicaid.gov). Prices reflect national average acquisition costs for retail community pharmacies.
No patent or exclusivity listings for this strength.