Propine

NDA 18239, held by Allergan. Dipivefrin Hydrochloride.

As of Nov 13, 2026, NDA 18239 (Propine), held by Allergan, was first approved by FDA on May 2, 1980, with 25 approved supplements and 0 published complete response letters.

First approved: May 2, 1980
Review: Priority
Supplements approved: 25
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 26 submissions below

Date	Submission	Status	Documents
May 2, 1980	Original applicationNew dosage form · Priority review	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Propine0.1% · solution/drops;ophthalmic	Dipivefrin Hydrochloride	Discontinued

All 26 submissions, including labeling and manufacturing supplements

Date	Submission	Status	Documents
Mar 19, 2003	Supplement 31Labeling · Standard review	Approved	None posted
Apr 12, 2002	Supplement 29Manufacturing · Priority review	Approved	None posted
Dec 4, 2001	Supplement 27Manufacturing · Priority review	Approved	None posted
Jul 20, 2001	Supplement 25Manufacturing · Priority review	Approved	Label
Apr 12, 2001	Supplement 26Manufacturing · Priority review	Approved	None posted
Oct 2, 2000	Supplement 24Manufacturing · Priority review	Approved	None posted
Mar 7, 2000	Supplement 23Manufacturing · Priority review	Approved	None posted
Oct 22, 1998	Supplement 22Manufacturing · Priority review	Approved	None posted
Apr 18, 1997	Supplement 21Manufacturing · Priority review	Approved	None posted
Aug 3, 1995	Supplement 20Manufacturing · Priority review	Approved	None posted
Jan 13, 1994	Supplement 19Manufacturing · Priority review	Approved	None posted
Oct 23, 1989	Supplement 17Labeling	Approved	None posted
Oct 23, 1989	Supplement 16Manufacturing · Priority review	Approved	None posted
Oct 11, 1989	Supplement 18Manufacturing · Priority review	Approved	None posted
Feb 9, 1988	Supplement 14Labeling	Approved	None posted
Aug 12, 1987	Supplement 5Manufacturing · Priority review	Approved	None posted
May 14, 1987	Supplement 13Manufacturing · Priority review	Approved	None posted
Apr 9, 1987	Supplement 6Labeling	Approved	None posted
Oct 16, 1986	Supplement 12Manufacturing · Priority review	Approved	None posted
Dec 2, 1983	Supplement 9Labeling	Approved	None posted
Sep 2, 1982	Supplement 3Manufacturing · Priority review	Approved	None posted
Sep 2, 1982	Supplement 2Manufacturing · Priority review	Approved	None posted
Aug 13, 1982	Supplement 7Manufacturing · Priority review	Approved	None posted
Oct 22, 1980	Supplement 4Manufacturing · Priority review	Approved	None posted
Jun 5, 1980	Supplement 1Labeling	Approved	None posted
May 2, 1980	Original applicationNew dosage form · Priority review	Approved	None posted

Identifiers

Application: NDA 18239
Drugs@FDA: Overview at FDA
Company: Allergan

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