ALENDRONATE SODIUM | N020560 | ORGANON LLC A SUB OF ORGANON AND CO
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Citizen Petition From Clinipace Worldwide FDA-2014-P-0861 Clinipace Worldwide filed this citizen petition on behalf of a client requesting that the FDA determine whether Merck's discontinued FOSAMAX (alendronate sodium) tablets in 10 mg, 35 mg, and 40 mg strengths under NDA 20560 were withdrawn for reasons of safety or effectiveness, and if not, to accept | 505(q) | 2014-07-02 | Open | Clinipace Worldwide |
Source: Regulations.gov. FDA citizen petitions matched by application number.
No patent or exclusivity listings for this strength.