Kadian

NDA 20616, held by Allergan. Morphine Sulfate.

As of Nov 15, 2026, NDA 20616 (Kadian), held by Allergan, was first approved by FDA on Jul 3, 1996, with 33 approved supplements and 0 published complete response letters.

First approved: Jul 3, 1996
Review: Standard
Supplements approved: 33
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 34 submissions below

Date	Submission	Status	Documents
Jul 3, 1996	Original applicationNew dosage form · Standard review	Approved	Other

Products

12 strengths and forms


Kadian20MG · capsule, extended release;oral	Morphine Sulfate	DiscontinuedReference drug
Kadian50MG · capsule, extended release;oral	Morphine Sulfate	DiscontinuedReference drug
Kadian100MG · capsule, extended release;oral	Morphine Sulfate	DiscontinuedReference drug
Kadian30MG · capsule, extended release;oral	Morphine Sulfate	DiscontinuedReference drug
Kadian60MG · capsule, extended release;oral	Morphine Sulfate	DiscontinuedReference drug
Kadian80MG · capsule, extended release;oral	Morphine Sulfate	DiscontinuedReference drug
Kadian200MG · capsule, extended release;oral	Morphine Sulfate	DiscontinuedReference drug
Kadian10MG · capsule, extended release;oral	Morphine Sulfate	DiscontinuedReference drug
Kadian40MG · capsule, extended release;oral	Morphine Sulfate	DiscontinuedReference drug
Kadian70MG · capsule, extended release;oral	Morphine Sulfate	DiscontinuedReference drug
Kadian130MG · capsule, extended release;oral	Morphine Sulfate	DiscontinuedReference drug
Kadian150MG · capsule, extended release;oral	Morphine Sulfate	DiscontinuedReference drug

All 34 submissions, including labeling and manufacturing supplements


Mar 4, 2021	Supplement 65Labeling · Standard review	Approved	Label Medication Guide Letter
Oct 7, 2019	Supplement 63Labeling · Standard review	Approved	Label Letter
Sep 18, 2018	Supplement 62Labeling · Standard review	Approved	Label Letter
Sep 18, 2018	Supplement 61REMS	Approved	Label Letter
May 26, 2017	Supplement 60REMS	Approved	Letter
Dec 16, 2016	Supplement 57Labeling · Standard review	Approved	Label Letter
Sep 30, 2016	Supplement 58REMS	Approved	Letter
Apr 20, 2016	Supplement 55REMS	Approved	Letter
Jun 26, 2015	Supplement 54REMS	Approved	Letter
Aug 19, 2014	Supplement 53REMS	Approved	Letter
Apr 16, 2014	Supplement 51Labeling	Approved	Letter Label
Apr 14, 2014	Supplement 52Manufacturing · Standard review	Approved	None posted
Apr 15, 2013	Supplement 47REMS	Approved	Letter
Mar 27, 2013	Supplement 48Labeling · Standard review	Approved	Letter
Jan 14, 2013	Supplement 46Manufacturing · Standard review	Approved	None posted
Jul 9, 2012	Supplement 44Manufacturing · Standard review	Approved	Label
Jul 9, 2012	Supplement 41REMS	Approved	Label Letter
Jul 9, 2012	Supplement 36Labeling · Standard review	Approved	None posted
Jan 31, 2008	Supplement 28Manufacturing	Approved	None posted
Apr 20, 2007	Supplement 25Manufacturing	Approved	Letter Label
Feb 27, 2007	Supplement 21Labeling · Standard review	Approved	Review Label Letter
Feb 27, 2007	Supplement 17Manufacturing · Standard review	Approved	Review Letter Label
Oct 27, 2006	Supplement 22Manufacturing	Approved	Letter Label
Sep 28, 2005	Supplement 10Manufacturing · Standard review	Approved	Letter Label
Mar 28, 2002	Supplement 9Manufacturing · Standard review	Approved	None posted
Dec 21, 2001	Supplement 7Manufacturing · Standard review	Approved	None posted
Dec 18, 2001	Supplement 8Manufacturing · Standard review	Approved	None posted
Mar 9, 2001	Supplement 4Manufacturing · Standard review	Approved	None posted
Feb 8, 2001	Supplement 6Manufacturing · Standard review	Approved	None posted
Feb 28, 2000	Supplement 5Manufacturing · Standard review	Approved	None posted
Jul 16, 1999	Supplement 3Labeling · Standard review	Approved	None posted
Apr 8, 1998	Supplement 2Manufacturing · Standard review	Approved	None posted
Jul 29, 1997	Supplement 1Labeling · Standard review	Approved	Review
Jul 3, 1996	Original applicationNew dosage form · Standard review	Approved	Other

Identifiers

Application: NDA 20616
Drugs@FDA: Overview at FDA
Company: Allergan

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