Enoxaparin Sodium

ANDA 78660, held by Sandoz Inc. Enoxaparin Sodium.

As of Nov 15, 2026, ANDA 78660 (Enoxaparin Sodium), held by Sandoz Inc, was first approved by FDA on Nov 28, 2011, with 4 approved supplements and 0 published complete response letters.

First approved: Nov 28, 2011
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
Nov 28, 2011	Original application	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Enoxaparin Sodium300MG/3ML (100MG/ML) · injectable;intravenous, subcutaneous	Enoxaparin Sodium	Rx

All 5 submissions, including labeling and manufacturing supplements


Jan 5, 2023	Supplement 19Labeling · Standard review	Approved	None posted
Dec 28, 2015	Supplement 12Labeling · Standard review	Approved	None posted
Oct 29, 2013	Supplement 11Labeling · Standard review	Approved	None posted
Jan 31, 2013	Supplement 2Labeling	Approved	None posted
Nov 28, 2011	Original application	Approved	None posted

Identifiers

Application: ANDA 78660
Drugs@FDA: Overview at FDA
Company: Sandoz

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