Daptomycin

ANDA 91039, held by Teva Pharms USA. Daptomycin.

As of Nov 13, 2026, ANDA 91039 (Daptomycin), held by Teva Pharms USA, was first approved by FDA on Mar 25, 2016, with 4 approved supplements and 0 published complete response letters.

First approved: Mar 25, 2016
Supplements approved: 4
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 5 submissions below

Date	Submission	Status	Documents
Mar 25, 2016	Original application	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Daptomycin500MG/VIAL · powder;intravenous	Daptomycin	Rx

All 5 submissions, including labeling and manufacturing supplements

Date	Submission	Status	Documents
Nov 12, 2019	Supplement 2Labeling · Standard review	Approved	None posted
Nov 12, 2019	Supplement 3Labeling · Standard review	Approved	None posted
Nov 12, 2019	Supplement 4Labeling · Standard review	Approved	None posted
Dec 21, 2016	Supplement 1Labeling · Standard review	Approved	None posted
Mar 25, 2016	Original application	Approved	None posted

Identifiers

Application: ANDA 91039
Drugs@FDA: Overview at FDA
Company: Teva Pharmaceuticals USA

Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed weekly; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters