Salagen

Treats symptoms of dry mouth from salivary gland hypofunction caused by radiotherapy for…. NDA 20237, held by Advanz Pharma. Pilocarpine Hydrochloride.

As of Nov 14, 2026, NDA 20237 (Salagen), held by Advanz Pharma, was first approved by FDA on Mar 22, 1994, with 14 approved supplements and 0 published complete response letters.

First approved: Mar 22, 1994
Review: Priority
Supplements approved: 14
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

INDICATIONS AND USAGE Pilocarpine Hydrochloride Tablets are indicated for 1) the treatment of symptoms of dry mouth from salivary gland hypofunction caused by radiotherapy for cancer of the head and neck; and 2) the treatment of symptoms of dry mouth in patients with Sjogren's Syndrome.

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 15 submissions below


Feb 11, 1998	Supplement 7Efficacy (new indication or use) · Standard review	Approved	Letter Review
Mar 22, 1994	Original applicationNew dosage form · Priority review	Approved	None posted

Products

2 strengths and forms


Salagen5MG · tablet;oral	Pilocarpine Hydrochloride	RxReference drug
Salagen7.5MG · tablet;oral	Pilocarpine Hydrochloride	RxReference drug

All 15 submissions, including labeling and manufacturing supplements


Sep 10, 2015	Supplement 21Manufacturing · Priority review	Approved	None posted
Apr 26, 2013	Supplement 20Manufacturing · Priority review	Approved	None posted
Apr 18, 2003	Supplement 12Manufacturing · Priority review	Approved	Review Letter Label
Sep 4, 2002	Supplement 11Manufacturing · Priority review	Approved	None posted
Jun 10, 2002	Supplement 9Labeling · Standard review	Approved	Letter Label
Jun 10, 2002	Supplement 8Labeling · Standard review	Approved	Letter Label
Feb 4, 2000	Supplement 10Manufacturing · Priority review	Approved	None posted
Feb 11, 1998	Supplement 7Efficacy (new indication or use) · Standard review	Approved	Letter Review
Mar 11, 1997	Supplement 6Labeling · Standard review	Approved	None posted
Sep 27, 1996	Supplement 5Labeling · Standard review	Approved	None posted
Apr 18, 1996	Supplement 1Manufacturing · Priority review	Approved	None posted
Nov 9, 1995	Supplement 4Manufacturing · Priority review	Approved	Letter
Nov 9, 1995	Supplement 3Manufacturing · Priority review	Approved	None posted
Nov 9, 1995	Supplement 2Manufacturing · Priority review	Approved	Letter
Mar 22, 1994	Original applicationNew dosage form · Priority review	Approved	None posted

Identifiers

Application: NDA 20237
Drugs@FDA: Overview at FDA
Company: ADVANZ PHARMA

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