Hydrocodone Bitartrate

Manages severe and persistent pain. ANDA 206986, held by Alvogen. Hydrocodone Bitartrate.

As of Nov 15, 2026, ANDA 206986 (Hydrocodone Bitartrate), held by Alvogen, was first approved by FDA on Jan 21, 2020, with 6 approved supplements and 0 published complete response letters.

First approved: Jan 21, 2020
Review: Standard
Supplements approved: 6
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

Hydrocodone bitartrate extended-release capsules 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 capsules, 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 7 submissions below

Date	Submission	Status	Documents
Jan 21, 2020	Original application	Approved	REMS Letter

Products

6 strengths and forms


Hydrocodone Bitartrate10MG · capsule, extended release;oral	Hydrocodone Bitartrate	Rx
Hydrocodone Bitartrate15MG · capsule, extended release;oral	Hydrocodone Bitartrate	Rx
Hydrocodone Bitartrate20MG · capsule, extended release;oral	Hydrocodone Bitartrate	Rx
Hydrocodone Bitartrate30MG · capsule, extended release;oral	Hydrocodone Bitartrate	Rx
Hydrocodone Bitartrate40MG · capsule, extended release;oral	Hydrocodone Bitartrate	Rx
Hydrocodone Bitartrate50MG · capsule, extended release;oral	Hydrocodone Bitartrate	Rx

All 7 submissions, including labeling and manufacturing supplements


Jun 18, 2026	Supplement 10REMS	Approved	None posted
Dec 22, 2025	Supplement 8Labeling · Standard review	Approved	None posted
Sep 26, 2025	Supplement 6Labeling · Standard review	Approved	None posted
Oct 31, 2024	Supplement 7REMS	Approved	None posted
Dec 15, 2023	Supplement 5Labeling · Standard review	Approved	None posted
Dec 11, 2023	Supplement 3Labeling · Standard review	Approved	None posted
Jan 21, 2020	Original application	Approved	REMS Letter

Identifiers

Application: ANDA 206986
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