Pilopine Hs

NDA 18796, held by Alcon. Pilocarpine Hydrochloride.

As of Nov 13, 2026, NDA 18796 (Pilopine Hs), held by Alcon, was first approved by FDA on Oct 1, 1984, with 11 approved supplements and 0 published complete response letters.

First approved: Oct 1, 1984
Review: Standard
Supplements approved: 11
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 12 submissions below

Date	Submission	Status	Documents
Oct 1, 1984	Original applicationNew dosage form · Standard review	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Pilopine Hs4% · gel;ophthalmic	Pilocarpine Hydrochloride	Discontinued

All 12 submissions, including labeling and manufacturing supplements

Date	Submission	Status	Documents
Apr 17, 2008	Supplement 14Labeling · Standard review	Approved	Label Letter
Dec 10, 1999	Supplement 12Manufacturing · Standard review	Approved	None posted
Oct 16, 1997	Supplement 11Manufacturing · Standard review	Approved	None posted
Nov 29, 1996	Supplement 9Manufacturing · Standard review	Approved	None posted
Oct 27, 1993	Supplement 8Manufacturing · Standard review	Approved	None posted
Apr 13, 1993	Supplement 7Manufacturing · Standard review	Approved	None posted
Dec 31, 1991	Supplement 6Manufacturing · Standard review	Approved	None posted
Dec 31, 1991	Supplement 5Labeling	Approved	None posted
Dec 13, 1988	Supplement 4Manufacturing · Standard review	Approved	None posted
Oct 17, 1988	Supplement 1Labeling	Approved	None posted
Jun 24, 1987	Supplement 3Manufacturing · Standard review	Approved	None posted
Oct 1, 1984	Original applicationNew dosage form · Standard review	Approved	None posted

Identifiers

Application: NDA 18796
Drugs@FDA: Overview at FDA
Company: Alcon

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