RISEDRONATE SODIUM | N020835 | ALLERGAN PHARMACEUTICALS INTERNATIONAL LTD
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Apotex, Inc. - Citizen Petition FDA-2010-P-0346 · 3 docket documents Apotex Inc. filed this petition on June 25, 2010, requesting that the FDA determine whether ACTONEL (Risedronate Sodium) Tablets, 75 mg, approved under NDA No. 20-835 and manufactured by Warner Chilcott, was withdrawn from the market for reasons of safety or effectiveness, as required under 21 C.F.R | 505(q) | 2010-07-06 | Withdrawn | — |
Apotex, Inc. - Citizen Petition FDA-2010-P-0342 · 3 docket documents Apotex Inc. filed this citizen petition on June 25, 2003, requesting that the FDA determine whether Actonel with Calcium (copackaged) (risedronate sodium 35 mg and calcium carbonate 1250 mg tablets), approved under NDA No. 21-823, was voluntarily withdrawn from the market for reasons of safety or ef | 505(q) | 2010-07-06 | Withdrawn | — |
Lachman Consultant Services, Inc. - Citizen Petition FDA-2010-P-0027 · 4 docket documents Lachman Consultant Services, Inc., filing on behalf of a client, submitted a citizen petition requesting that the FDA determine whether Actonel (risedronate sodium) Tablets, 75 mg (NDA 020835), manufactured by Procter and Gamble, was withdrawn from sale for safety or effectiveness reasons pursuant t | 505(q) | 2010-01-21 | Granted | — |
Source: Regulations.gov. FDA citizen petitions matched by application number.
Highest NADAC/Unit
$81.86
per ea
Lowest NADAC/Unit
$2.40
per ea
Brand NDCs
1
Generic NDCs
2
| NDC Description | NADAC/Unit | Unit | Type | Generic NADAC | Effective |
|---|---|---|---|---|---|
| 00430047203ACTONEL 35 MG TABLET | $81.86 | EA | Brand | $2.40 | 2026-01-21 |
| 59762040601RISEDRONATE SODIUM 150 MG TAB | $13.89 | EA | Generic | — | 2026-06-17 |
| 59762040504RISEDRONATE SODIUM 35 MG TABLET | $2.40 | EA | 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.