RISEDRONATE SODIUM | A077132 | TEVA PHARMACEUTICALS USA
| 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ACTONEL (Risedronate Sodium) Tablets, 75 mg, approved under NDA No. 20-835 and manufactured by Warner Chilcott, was withdrawn from the market for reasons of safety or effectiveness, as required under 21 C.F.R | 505(q) | 2010-07-06 | Withdrawn | — |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(risedronate sodium 35 mg and calcium carbonate 1250 mg tablets), approved under NDA No. 21-823, was voluntarily withdrawn from the market for reasons of safety or ef | 505(q) | 2010-07-06 | Withdrawn | — |
Source: Regulations.gov. FDA citizen petitions matched by application number.
Highest NADAC/Unit
$2.40
per ea
Lowest NADAC/Unit
$1.42
per ea
Brand NDCs
0
Generic NDCs
3
| NDC Description | NADAC/Unit | Unit | Type | Generic NADAC | Effective |
|---|---|---|---|---|---|
| 00093309829RISEDRONATE SODIUM 35 MG TAB | $2.40 | EA | Generic | — | 2026-06-17 |
| 00093309844RISEDRONATE SODIUM 35 MG TAB | $2.40 | EA | Generic | — | 2026-06-17 |
| 00093309956RISEDRONATE SODIUM 5 MG TABLET | $1.42 | 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.