Captopril

ANDA 74418, held by Tp Anda Holdings. Captopril.

As of Nov 13, 2026, ANDA 74418 (Captopril), held by Tp Anda Holdings, was first approved by FDA on Feb 13, 1996, with 5 approved supplements and 0 published complete response letters.

First approved: Feb 13, 1996
Supplements approved: 5
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 6 submissions below

Date	Submission	Status	Documents
Feb 13, 1996	Original application	Approved	None posted

Products

4 strengths and forms

Product	Active ingredient	Marketing
Captopril12.5MG · tablet;oral	Captopril	Discontinued
Captopril25MG · tablet;oral	Captopril	Discontinued
Captopril50MG · tablet;oral	Captopril	Discontinued
Captopril100MG · tablet;oral	Captopril	Discontinued

All 6 submissions, including labeling and manufacturing supplements

Date	Submission	Status	Documents
Jul 18, 2002	Supplement 5Manufacturing	Approved	None posted
Oct 14, 1997	Supplement 4Labeling	Approved	None posted
Feb 13, 1997	Supplement 3Labeling	Approved	None posted
Oct 31, 1996	Supplement 2Labeling	Approved	None posted
Oct 31, 1996	Supplement 1Manufacturing	Approved	None posted
Feb 13, 1996	Original application	Approved	None posted

Identifiers

Application: ANDA 74418
Drugs@FDA: Overview at FDA
Company: TP ANDA Holdings

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