FLUTICASONE PROPIONATE | A076668 | PADAGIS ISRAEL PHARMACEUTICALS LTD
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Citizen Petition from BF Innovation, Inc. FDA-2020-P-2146 · 3 docket documents BF Innovation Inc., acting on behalf of Bright Future Pharmaceutical Laboratories Limited, filed this citizen petition requesting FDA confirmation that CUTIVATE (Fluticasone Propionate Ointment 0.005%), the Reference Listed Drug approved under NDA N019957 and held by Fougera Pharmaceuticals Inc., wa | Other | 2020-11-03 | Denied | BF Innovation, Inc. |
Citizen Petition from BF Innovation Inc on behalf of Bright Future Pharmaceut... FDA-2018-P-3746 · 5 docket documents BF Innovation Inc., on behalf of Bright Future Pharmaceutical Laboratories Limited, submitted a citizen petition requesting that the FDA designate Fluticasone Propionate Ointment 0.005% (Application No. A076668) by Perrigo New York Inc. as an additional Reference Standard under Section 505(j) of the | 505(q) | 2018-10-03 | Open | Bright Future Pharmaceutical Laboratories Limited |
Source: Regulations.gov. FDA citizen petitions matched by application number.
Highest NADAC/Unit
$0.6257
per gm
Lowest NADAC/Unit
$0.3616
per gm
Brand NDCs
0
Generic NDCs
3
| NDC Description | NADAC/Unit | Unit | Type | Generic NADAC | Effective |
|---|---|---|---|---|---|
| 45802022135FLUTICASONE PROP 0.005% OINT | $0.6257 | GM | Generic | — | 2026-06-17 |
| 45802022111FLUTICASONE PROP 0.005% OINT | $0.5056 | GM | Generic | — | 2026-06-17 |
| 45802022137FLUTICASONE PROP 0.005% OINT | $0.3616 | GM | Generic | — | 2026-06-17 |
Source: NADAC (data.medicaid.gov). Prices reflect national average acquisition costs for retail community pharmacies.
No patent or exclusivity listings for this strength.