MYCOPHENOLATE MOFETIL | N050759 | ROCHE PALO ALTO LLC
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Citizen Petition from Haynes and Boone LLP FDA-2018-P-1014 · 14 docket documents Haynes and Boone LLP filed this citizen petition on behalf of Vertice Pharma LLC requesting that the FDA deny approval to any ANDA for mycophenolate mofetil oral suspension that relies solely on metabolite data to establish bioequivalence, withdraw the current draft guidance permitting metabolite-on | 505(q) | 2018-03-07 | Denied | Haynes and Boone LLP |
Boehringer Ingelhein Roxane Laboratories, Inc. - Citizen Petition FDA-2010-P-0076 · 5 docket documents Roxane Laboratories, Inc. submitted a citizen petition under 21 C.F.R. § 10.30 requesting that the FDA ensure generic drug manufacturers have appropriate roles in developing and implementing Risk Evaluation and Mitigation Strategies (REMS) programs, particularly for mycophenolate mofetil, and that b | 505(q) | 2010-02-18 | Withdrawn | — |
Hoffmann-LaRoche Inc., and Roche Palo Alto LLC [Arnold & Porter, LLP] - Citiz... FDA-2009-P-0103 · 3 docket documents Hoffmann-LaRoche Inc. and Roche Palo Alto LLC filed this petition requesting that FDA stay approval of Apotex's ANDAs 90-499 and 90-419 for generic mycophenolate mofetil (Cellcept) until the earlier of thirty months from receipt of Paragraph IV certification notice, resolution of their patent infrin | 505(q) Stay Request | 2009-02-26 | Denied | — |
Source: Regulations.gov. FDA citizen petitions matched by application number.
Highest NADAC/Unit
$8.33
per ml
Lowest NADAC/Unit
$8.33
per ml
Brand NDCs
1
Generic NDCs
0
| NDC Description | NADAC/Unit | Unit | Type | Generic NADAC | Effective |
|---|---|---|---|---|---|
| 00004026129CELLCEPT 200 MG/ML ORAL SUSP | $8.33 | ML | Brand | $0.9324 | 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.