Viewing data from:

KADIAN

NDA

MORPHINE SULFATE | N020616 | ALLERGAN SALES LLC

12 strengths0 unique patents0 unique exclusivities

PTAB Proceedings

No IPR/PGR/CBM challenges found at the Patent Trial and Appeal Board

Patent Reexaminations

No ex parte or inter partes reexamination proceedings found at USPTO

Hatch-Waxman Litigation

No ANDA patent litigation cases (NOS 835) matched from PACER

Citizen Petitions

No FDA citizen petitions matched from Regulations.gov

Clinical Trials

No clinical trials found on ClinicalTrials.gov for this drug

API Supply Chain3 active DMFs5 inactive

3 active API suppliers hold Drug Master Files for this ingredient.

SPECGX LLCMORPHINE SULFATE

DMF 58571985

NORAMCO LLCMORPHINE SULFATE

DMF 69671987

VERANOVA LPMORPHINE SULFATE USP

DMF 215882008

PENICK CORPInactiveMORPHINE SULFATE

DMF 66801986

MACFARLAN SMITH LTDInactiveMORPHINE SULFATE

DMF 83281989

MALLINCKRODT INCInactiveMORPHINE SULFATE INJECTION USP

DMF 115291995

ELAN PHARMA LTDInactiveMORPHINE SULFATE

DMF 128081997

SIEGFRIED USA LLCInactiveMORPHINE SULFATE USP

DMF 196932006

Source: FDA Drug Master Files (fda.gov). Type II API DMFs matched by ingredient.

Approval Letters

19 letters from Drugs@FDA

Date	Submission	Document
Mar 5, 2021	SUPPL -65	View Letter (PDF)
Oct 8, 2019	SUPPL -63	View Letter (PDF)
Sep 28, 2018	SUPPL -61	View Letter (PDF)
Sep 28, 2018	SUPPL -62	View Letter (PDF)
May 30, 2017	SUPPL -60	View Letter (PDF)
Dec 20, 2016	SUPPL -57	View Letter (PDF)
Oct 4, 2016	SUPPL -58	View Letter (PDF)
Apr 22, 2016	SUPPL -55	View Letter (PDF)
Jul 2, 2015	SUPPL -54	View Letter (PDF)
Aug 20, 2014	SUPPL -53	View Letter (PDF)
Apr 17, 2014	SUPPL -51	View Letter (PDF)
Apr 17, 2013	SUPPL -47	View Letter (PDF)
Mar 29, 2013	SUPPL -48	View Letter (PDF)
Jul 11, 2012	SUPPL -41	View Letter (PDF)
May 1, 2007	SUPPL -25	View Letter (PDF)
Mar 7, 2007	SUPPL -17	View Letter (PDF)
Mar 7, 2007	SUPPL -21	View Letter (PDF)
Nov 6, 2006	SUPPL -22	View Letter (PDF)
Oct 20, 2005	SUPPL -10	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (12)

Sort:

#001 — 20MG

RLD

0 patents0 exclusivities▴

CAPSULE, EXTENDED RELEASE;ORAL | Approved: Jul 3, 1996

No patent or exclusivity listings for this strength.

#002 — 50MG

RLD

0 patents0 exclusivities▾

CAPSULE, EXTENDED RELEASE;ORAL | Approved: Jul 3, 1996

#003 — 100MG

RLD

0 patents0 exclusivities▾

CAPSULE, EXTENDED RELEASE;ORAL | Approved: Jul 3, 1996

#004 — 30MG

RLD

0 patents0 exclusivities▾

CAPSULE, EXTENDED RELEASE;ORAL | Approved: Mar 9, 2001

#005 — 60MG

RLD

0 patents0 exclusivities▾

CAPSULE, EXTENDED RELEASE;ORAL | Approved: Mar 9, 2001

#006 — 80MG

RLD

0 patents0 exclusivities▾

CAPSULE, EXTENDED RELEASE;ORAL | Approved: Oct 27, 2006

#007 — 200MG

RLD

0 patents0 exclusivities▾

CAPSULE, EXTENDED RELEASE;ORAL | Approved: Feb 27, 2007

#008 — 10MG

RLD

0 patents0 exclusivities▾

CAPSULE, EXTENDED RELEASE;ORAL | Approved: Apr 20, 2007

#009 — 40MG

RLD

0 patents0 exclusivities▾

CAPSULE, EXTENDED RELEASE;ORAL | Approved: Jul 9, 2012

#010 — 70MG

RLD

0 patents0 exclusivities▾

CAPSULE, EXTENDED RELEASE;ORAL | Approved: Jul 9, 2012

#011 — 130MG

RLD

0 patents0 exclusivities▾

CAPSULE, EXTENDED RELEASE;ORAL | Approved: Jul 9, 2012

#012 — 150MG

RLD

0 patents0 exclusivities▾

CAPSULE, EXTENDED RELEASE;ORAL | Approved: Jul 9, 2012