DOXERCALCIFEROL | N021027 | SANOFI GENZYME
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Suitability Petition from GLAND PHARMA LIMITED FDA-2020-P-1859 · 6 docket documents 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 | Denied | 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Hecterol (doxercalciferol) Injection Ampule formulation, 2 mcg/mL (NDA 21-027), held by Genzyme, has been voluntarily withdrawn for safety or efficacy reasons under 21 CFR 314.161 an | 505(q) | 2009-02-20 | Partially Denied | — |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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