Zohydro Er

NDA 202880, held by Recro Gainesville. Hydrocodone Bitartrate.

As of Nov 13, 2026, NDA 202880 (Zohydro Er), held by Recro Gainesville, was first approved by FDA on Oct 25, 2013, with 13 approved supplements and 0 published complete response letters.

First approved: Oct 25, 2013
Review: Standard
Supplements approved: 13
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 14 submissions below

Date	Submission	Status	Documents
Oct 25, 2013	Original applicationNew dosage form · Standard review	Approved	Review Other Summary Review Letter

Products

6 strengths and forms


Zohydro Er10MG · capsule, extended release;oral	Hydrocodone Bitartrate	DiscontinuedReference drug
Zohydro Er15MG · capsule, extended release;oral	Hydrocodone Bitartrate	DiscontinuedReference drug
Zohydro Er20MG · capsule, extended release;oral	Hydrocodone Bitartrate	DiscontinuedReference drug
Zohydro Er30MG · capsule, extended release;oral	Hydrocodone Bitartrate	DiscontinuedReference drug
Zohydro Er40MG · capsule, extended release;oral	Hydrocodone Bitartrate	DiscontinuedReference drug
Zohydro Er50MG · capsule, extended release;oral	Hydrocodone Bitartrate	DiscontinuedReference drug

All 14 submissions, including labeling and manufacturing supplements


Mar 4, 2021	Supplement 20Labeling · Standard review	Approved	Letter Label Medication Guide
Oct 7, 2019	Supplement 19Labeling · Standard review	Approved	Label Letter
Sep 18, 2018	Supplement 14REMS	Approved	Letter Label
Sep 18, 2018	Supplement 15Labeling · Standard review	Approved	Letter Label
May 26, 2017	Supplement 12REMS	Approved	Letter
Dec 16, 2016	Supplement 9Labeling · Standard review	Approved	Letter Label
Dec 16, 2016	Supplement 10Labeling · Standard review	Approved	Letter Label
Sep 30, 2016	Supplement 11REMS	Approved	Letter
Apr 20, 2016	Supplement 7REMS	Approved	Letter
Jun 26, 2015	Supplement 6REMS	Approved	Letter
Jan 30, 2015	Supplement 3Manufacturing	Approved	Label Summary Review Letter
Sep 22, 2014	Supplement 1Manufacturing · Standard review	Approved	None posted
Aug 19, 2014	Supplement 2Labeling · Standard review	Approved	Label Letter
Oct 25, 2013	Original applicationNew dosage form · Standard review	Approved	Review Other Summary Review Letter

Identifiers

Application: NDA 202880
Drugs@FDA: Overview at FDA
Company: Recro Gainesville

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