DOXERCALCIFEROL | N208614 | HOSPIRA INC
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Denial Letter Final response for Suitability Petition from FDA CDER to Gland ... FDA-2020-P-1859 · 6 docket documents 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 | Denied | FDA CDER to Gland Pharma Limited |
Genzyme Corporation (Covington & Burling LLP) - Citizen Petition FDA-2010-P-0223 · 9 docket documents Genzyme Corporation, through counsel, filed this citizen petition pursuant to section 505(j) of the Federal Food, Drug, and Cosmetic Act requesting that FDA confirm it will maintain a 30-month stay of approval for ANDA No. 90-040 (a generic version of Hectorol doxercalciferol) beginning November 24, | 505(q) Stay Request | 2010-04-29 | Granted | — |
Lachman Consultant Services, Inc. - Citizen Petition FDA-2009-P-0088 · 4 docket documents Lachman Consultant Services, Inc. filed this petition on behalf of a client requesting that the FDA determine whether Hecterol (doxercalciferol) Injection Ampule formulation, 2 mcg/mL (NDA 21-027), held by Genzyme, has been voluntarily withdrawn for safety or efficacy reasons under 21 CFR 314.161 an | 505(q) | 2009-02-20 | Partially Denied | — |
Source: Regulations.gov. FDA citizen petitions matched by application number.
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