Naproxen

ANDA 215776, held by Hetero Labs Ltd Iii. Naproxen.

As of Nov 14, 2026, ANDA 215776 (Naproxen), held by Hetero Labs Ltd Iii, was first approved by FDA on Jun 7, 2022, with 2 approved supplements and 0 published complete response letters.

First approved: Jun 7, 2022
Review: Standard
Supplements approved: 2
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

Naproxen oral suspension is indicated for: the relief of the signs and symptoms of:

rheumatoid arthritis
osteoarthritis
ankylosing spondylitis
polyarticular juvenile idiopathic arthritis
tendonitis
bursitis
acute gout the management of:
pain
primary dysmenorrhea

Full prescribing information on DailyMed ↗

Approvals and New Uses

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

Date	Submission	Status	Documents
Jun 7, 2022	Original application	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Naproxen25MG/ML · suspension;oral	Naproxen	Rx

All 3 submissions, including labeling and manufacturing supplements


Jun 30, 2026	Supplement 3Labeling · Standard review	Approved	None posted
Dec 21, 2022	Supplement 1Labeling · Standard review	Approved	None posted
Jun 7, 2022	Original application	Approved	None posted

Identifiers

Application: ANDA 215776
Drugs@FDA: Overview at FDA
Company: Hetero Labs Ltd Iii

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