Reserpine

ANDA 80749, held by Watson Labs. Reserpine.

As of Nov 15, 2026, ANDA 80749 (Reserpine), held by Watson Labs, was first approved by FDA on Apr 25, 1973, with 1 approved supplement and 0 published complete response letters.

First approved: Apr 25, 1973
Supplements approved: 1
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 2 submissions below

Date	Submission	Status	Documents
Apr 25, 1973	Original application	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Reserpine1MG · tablet;oral	Reserpine	Discontinued

All 2 submissions, including labeling and manufacturing supplements


Sep 9, 1991	Supplement 10Labeling	Approved	None posted
Apr 25, 1973	Original application	Approved	None posted

Identifiers

Application: ANDA 80749
Drugs@FDA: Overview at FDA
Company: Watson Laboratories

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