Sumatriptan And Naproxen Sodium

ANDA 90872, held by Rising. Naproxen Sodium; Sumatriptan Succinate.

As of Nov 15, 2026, ANDA 90872 (Sumatriptan And Naproxen Sodium), held by Rising, was first approved by FDA on Sep 4, 2018, with 2 approved supplements and 0 published complete response letters.

First approved: Sep 4, 2018
Supplements approved: 2
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 3 submissions below

Date	Submission	Status	Documents
Sep 4, 2018	Original application	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Sumatriptan And Naproxen Sodium500MG;EQ 85MG BASE · tablet;oral	Naproxen Sodium; Sumatriptan Succinate	Rx

All 3 submissions, including labeling and manufacturing supplements


Feb 13, 2024	Supplement 2Labeling · Standard review	Approved	None posted
Mar 25, 2020	Supplement 1Labeling · Standard review	Approved	None posted
Sep 4, 2018	Original application	Approved	None posted

Identifiers

Application: ANDA 90872
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