Pilocarpine Hydrochloride

ANDA 76746, held by Padagis US. Pilocarpine Hydrochloride.

As of Nov 15, 2026, ANDA 76746 (Pilocarpine Hydrochloride), held by Padagis US, was first approved by FDA on Nov 16, 2004, with 2 approved supplements and 0 published complete response letters.

First approved: Nov 16, 2004
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
Nov 16, 2004	Original application	Approved	Letter

Products

1 strengths and forms

Product	Active ingredient	Marketing
Pilocarpine Hydrochloride5MG · tablet;oral	Pilocarpine Hydrochloride	Discontinued

All 3 submissions, including labeling and manufacturing supplements


Jul 25, 2011	Supplement 2Labeling	Approved	None posted
Jun 29, 2005	Supplement 1Labeling	Approved	None posted
Nov 16, 2004	Original application	Approved	Letter

Identifiers

Application: ANDA 76746
Drugs@FDA: Overview at FDA
Company: Padagis US LLC

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