Primsol

NDA 74374, held by Pangea. Trimethoprim Hydrochloride.

As of Nov 13, 2026, NDA 74374 (Primsol), held by Pangea, was first approved by FDA on Jun 23, 1995, with 2 approved supplements and 0 published complete response letters.

First approved: Jun 23, 1995
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
Jun 23, 1995	Original application	Approved	Review

Products

1 strengths and forms

Product	Active ingredient	Marketing
PrimsolEQ 25MG BASE/5ML · solution;oral	Trimethoprim Hydrochloride	Discontinued

All 3 submissions, including labeling and manufacturing supplements

Date	Submission	Status	Documents
Jun 17, 1997	Supplement 1Labeling	Approved	None posted
Jun 17, 1997	Supplement 2Manufacturing	Approved	None posted
Jun 23, 1995	Original application	Approved	Review

Identifiers

Application: NDA 74374
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