Melamisa

ANDA 202016, held by Novast Labs. Drospirenone; Ethinyl Estradiol.

As of Nov 15, 2026, ANDA 202016 (Melamisa), held by Novast Labs, was first approved by FDA on Jan 26, 2016, with 3 approved supplements and 0 published complete response letters.

First approved: Jan 26, 2016
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 26, 2016	Original application	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Melamisa3MG;0.02MG · tablet;oral	Drospirenone; Ethinyl Estradiol	Rx

All 4 submissions, including labeling and manufacturing supplements


Mar 21, 2025	Supplement 8Labeling · Standard review	Approved	None posted
Mar 21, 2025	Supplement 7Labeling · Standard review	Approved	None posted
Mar 21, 2025	Supplement 1Labeling · Standard review	Approved	None posted
Jan 26, 2016	Original application	Approved	None posted

Identifiers

Application: ANDA 202016
Drugs@FDA: Overview at FDA
Company: Novast 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