Yutopar

NDA 18555, held by Astrazeneca. Ritodrine Hydrochloride.

As of Nov 14, 2026, NDA 18555 (Yutopar), held by Astrazeneca, was first approved by FDA on Dec 12, 1980, with 8 approved supplements and 0 published complete response letters.

First approved: Dec 12, 1980
Review: Standard
Supplements approved: 8
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 9 submissions below

Date	Submission	Status	Documents
Dec 12, 1980	Original applicationNew formulation or manufacturer · Standard review	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Yutopar10MG · tablet;oral	Ritodrine Hydrochloride	Discontinued

All 9 submissions, including labeling and manufacturing supplements


Mar 27, 1996	Supplement 2Labeling	Approved	None posted
Mar 27, 1996	Supplement 5Labeling	Approved	None posted
Mar 27, 1996	Supplement 7Labeling	Approved	None posted
Mar 27, 1996	Supplement 14Labeling · Standard review	Approved	None posted
Mar 27, 1996	Supplement 15Labeling · Standard review	Approved	None posted
Jun 23, 1987	Supplement 13Labeling	Approved	None posted
Nov 19, 1986	Supplement 12Labeling	Approved	None posted
Apr 17, 1986	Supplement 11Labeling	Approved	None posted
Dec 12, 1980	Original applicationNew formulation or manufacturer · Standard review	Approved	None posted

Identifiers

Application: NDA 18555
Drugs@FDA: Overview at FDA
Company: AstraZeneca Pharmaceuticals LP

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