DOXERCALCIFEROL | N021027 | SANOFI GENZYME
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Denial Letter Final response for Suitability Petition from FDA CDER to Gland ... FDA-2020-P-1859 Gland Pharma Limited filed a suitability petition requesting permission to submit an ANDA for Doxercalciferol Injection at a higher strength of 10 mcg/5 mL, referencing the listed drug Hectorol® Injection approved under NDA 021027. The FDA denied the petition under section 505(j)(2)(C) of the Federa | Suitability | 2022-02-03 | Open | FDA CDER to Gland Pharma Limited |
Suitability Petition from GLAND PHARMA LIMITED FDA-2020-P-1859 Gland Pharma Limited submitted this suitability petition under Section 505(j)(2)(C) of the Federal Food, Drug, and Cosmetic Act requesting FDA approval to file a Prior Approval Supplement to an already-approved ANDA for Doxercalciferol Injection in a new strength of 10 mcg/5 mL (2 mcg/mL), which mai | Suitability | 2020-09-09 | Open | GLAND PHARMA LIMITED |
Source: Regulations.gov. FDA citizen petitions matched by application number.
No patent or exclusivity listings for this strength.