Yosprala

NDA 205103, held by Genus Lifesciences. Aspirin; Omeprazole.

As of Nov 15, 2026, NDA 205103 (Yosprala), held by Genus Lifesciences, was first approved by FDA on Sep 14, 2016, with 7 approved supplements and 0 published complete response letters.

First approved: Sep 14, 2016
Review: Standard
Supplements approved: 7
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 8 submissions below

Date	Submission	Status	Documents
Sep 14, 2016	Original applicationNew combination · Standard review	Approved	Review Letter Label

Products

2 strengths and forms


Yosprala81MG;40MG · tablet, delayed release;oral	Aspirin; Omeprazole	DiscontinuedReference drug
Yosprala325MG;40MG · tablet, delayed release;oral	Aspirin; Omeprazole	DiscontinuedReference drug

All 8 submissions, including labeling and manufacturing supplements


Nov 21, 2024	Supplement 10Labeling · Standard review	Approved	Label Medication Guide Letter
Jul 18, 2023	Supplement 9Labeling · Standard review	Approved	Label Letter
Mar 4, 2022	Supplement 8Labeling · Standard review	Approved	Label Letter
Apr 28, 2021	Supplement 7Labeling · Standard review	Approved	Label Letter
Nov 27, 2020	Supplement 6Labeling · Standard review	Approved	Letter Label
Jun 7, 2018	Supplement 4Labeling · Standard review	Approved	Letter Label
Oct 4, 2017	Supplement 1Labeling · Standard review	Approved	Letter Label
Sep 14, 2016	Original applicationNew combination · Standard review	Approved	Review Letter Label

Identifiers

Application: NDA 205103
Drugs@FDA: Overview at FDA
Company: Genus Lifesciences

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