Primsol

NDA 74973, held by Pangea. Trimethoprim Hydrochloride.

As of Nov 13, 2026, NDA 74973 (Primsol), held by Pangea, was first approved by FDA on Jan 24, 2000, with 3 approved supplements and 0 published complete response letters.

First approved: Jan 24, 2000
Supplements approved: 3
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 4 submissions below

Date	Submission	Status	Documents
Jan 24, 2000	Original application	Approved	Letter Review

Products

1 strengths and forms

Product	Active ingredient	Marketing
PrimsolEQ 50MG BASE/5ML · solution;oral	Trimethoprim Hydrochloride	DiscontinuedReference drug

All 4 submissions, including labeling and manufacturing supplements

Date	Submission	Status	Documents
Dec 21, 2016	Supplement 8Labeling · Standard review	Approved	Letter Label
Sep 8, 2014	Supplement 7Manufacturing	Approved	None posted
Mar 20, 2001	Supplement 1Manufacturing	Approved	None posted
Jan 24, 2000	Original application	Approved	Letter Review

Identifiers

Application: NDA 74973
Drugs@FDA: Overview at FDA
Company: Pangea Pharmaceuticals

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