Doxercalciferol

ANDA 201518, held by Rising. Doxercalciferol.

As of Nov 14, 2026, ANDA 201518 (Doxercalciferol), held by Rising, was first approved by FDA on Sep 9, 2016, with 1 approved supplement and 0 published complete response letters.

First approved: Sep 9, 2016
Supplements approved: 1
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 2 submissions below

Date	Submission	Status	Documents
Sep 9, 2016	Original application	Approved	None posted

Products

3 strengths and forms


Doxercalciferol0.5MCG · capsule;oral	Doxercalciferol	Rx
Doxercalciferol1MCG · capsule;oral	Doxercalciferol	Rx
Doxercalciferol2.5MCG · capsule;oral	Doxercalciferol	Rx

All 2 submissions, including labeling and manufacturing supplements


Nov 22, 2024	Supplement 1Labeling · Standard review	Approved	None posted
Sep 9, 2016	Original application	Approved	None posted

Identifiers

Application: ANDA 201518
Drugs@FDA: Overview at FDA
Company: Rising Pharmaceuticals

Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed daily; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters