Hydrocodone Bitartrate

Manages severe and persistent pain. ANDA 208269, held by Alvogen. Hydrocodone Bitartrate.

As of Nov 15, 2026, ANDA 208269 (Hydrocodone Bitartrate), held by Alvogen, was first approved by FDA on Mar 1, 2021, with 2 approved supplements and 0 published complete response letters.

First approved: Mar 1, 2021
Review: Standard
Supplements approved: 2
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

Hydrocodone bitartrate extended-release tablets are indicated for the management of severe and persistent pain that requires an opioid analgesic and that cannot be adequately treated with alternative options, including immediate-release opioids. Limitations of Use Because of the risks of addiction, abuse, misuse, overdose and death, which can occur at any dosage or duration and persist over the course of therapy, reserve opioid analgesics, including hydrocodone bitartrate extended-release tablets, for use in patients for whom alternative treatment options are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient management of pain.

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 3 submissions below

Date	Submission	Status	Documents
Mar 1, 2021	Original application	Approved	REMS Letter

Products

7 strengths and forms


Hydrocodone Bitartrate20MG · tablet, extended release;oral	Hydrocodone Bitartrate	Rx
Hydrocodone Bitartrate30MG · tablet, extended release;oral	Hydrocodone Bitartrate	Rx
Hydrocodone Bitartrate40MG · tablet, extended release;oral	Hydrocodone Bitartrate	Rx
Hydrocodone Bitartrate60MG · tablet, extended release;oral	Hydrocodone Bitartrate	Rx
Hydrocodone Bitartrate80MG · tablet, extended release;oral	Hydrocodone Bitartrate	Rx
Hydrocodone Bitartrate100MG · tablet, extended release;oral	Hydrocodone Bitartrate	Rx
Hydrocodone Bitartrate120MG · tablet, extended release;oral	Hydrocodone Bitartrate	Rx

All 3 submissions, including labeling and manufacturing supplements


Jun 18, 2026	Supplement 5REMS	Approved	None posted
Oct 31, 2024	Supplement 2REMS	Approved	None posted
Mar 1, 2021	Original application	Approved	REMS Letter

Identifiers

Application: ANDA 208269
Drugs@FDA: Overview at FDA
Company: Alvogen

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