CALCITRIOL | N018044 | ESJAY PHARMA LLC
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Suitability Petition from Windels Marx Lane & Mittendorf, LLP FDA-2025-P-1154 · 7 docket documents Windels Marx Lane & Mittendorf, LLP filed this suitability petition pursuant to Section 505(j)(2)(C) of the FDC Act requesting that FDA declare Calcitriol Capsules in 0.75 mcg, 1 mcg, and 2 mcg strengths suitable for submission as an ANDA, based on the reference listed drug ROCALTROL Capsules approv | Suitability | 2025-05-07 | Open | Windels Marx Lane & Mittendorf, LLP |
Anatase Biopharmaceutic Consulting LLC. - Citizen Petition FDA-2012-P-0549 · 4 docket documents Anatase Biopharmaceutic Consulting LLC, represented by Alfred T. Elvin, Ph.D., filed this petition on May 24, 2012, requesting that the FDA refrain from approving any pending or new applications submitted under 505(j) or 505(b)(2) for Calcitriol Capsules in 0.25 microgram and 0.5 microgram strengths | 505(q) | 2012-06-01 | Denied | — |
Anatase Biopharmaceutic Consulting LLC. - Citizen Petition FDA-2012-P-0412 · 3 docket documents Anatase Biopharmaceutic Consulting LLC filed this citizen petition under Section 505 of the FDC Act requesting that the FDA refrain from approving any pending or new applications submitted under 505(j) or 505(b)(2) for generic Calcitriol Capsules in 0.25 microgram and 0.5 microgram strengths unless | 505(q) | 2012-05-04 | Withdrawn | — |
Source: Regulations.gov. FDA citizen petitions matched by application number.
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