Drugs@FDA: FDA Approved Drug Products

Home | Previous Page

New Drug Application (NDA): 020616
Company: ALLERGAN
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
KADIAN MORPHINE SULFATE 20MG CAPSULE, EXTENDED RELEASE;ORAL Prescription AB Yes No
KADIAN MORPHINE SULFATE 50MG CAPSULE, EXTENDED RELEASE;ORAL Prescription AB Yes No
KADIAN MORPHINE SULFATE 100MG CAPSULE, EXTENDED RELEASE;ORAL Prescription AB Yes Yes
KADIAN MORPHINE SULFATE 30MG CAPSULE, EXTENDED RELEASE;ORAL Prescription AB Yes No
KADIAN MORPHINE SULFATE 60MG CAPSULE, EXTENDED RELEASE;ORAL Prescription AB Yes No
KADIAN MORPHINE SULFATE 80MG CAPSULE, EXTENDED RELEASE;ORAL Prescription AB Yes No
KADIAN MORPHINE SULFATE 200MG CAPSULE, EXTENDED RELEASE;ORAL Prescription None Yes Yes
KADIAN MORPHINE SULFATE 10MG CAPSULE, EXTENDED RELEASE;ORAL Prescription AB Yes Yes
KADIAN MORPHINE SULFATE 40MG CAPSULE, EXTENDED RELEASE;ORAL Prescription AB Yes No
KADIAN MORPHINE SULFATE 70MG CAPSULE, EXTENDED RELEASE;ORAL Prescription AB Yes No
KADIAN MORPHINE SULFATE 130MG CAPSULE, EXTENDED RELEASE;ORAL Prescription None Yes No
KADIAN MORPHINE SULFATE 150MG CAPSULE, EXTENDED RELEASE;ORAL Prescription None Yes No
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
07/03/1996 ORIG-1 Approval Type 3 - New Dosage Form STANDARD

Label is not available on this site.

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
10/07/2019 SUPPL-63 Labeling-Medication Guide, Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/020616s063lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/020616Orig1s063ltr.pdf
09/18/2018 SUPPL-62 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/020616s061s062lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/020616Orig1s061s062ltr.pdf
09/18/2018 SUPPL-61 REMS - MODIFIED - D-N-A Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/020616s061s062lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/020616Orig1s061s062ltr.pdf
05/26/2017 SUPPL-60 REMS-Modified Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/020616Orig1s060ltr.pdf
09/30/2016 SUPPL-58 REMS - MODIFIED - D-N-A Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/020616Orig1s058ltr.pdf
12/16/2016 SUPPL-57 Labeling-Package Insert, Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020616s057lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/020616Orig1s057ltr.pdf
04/20/2016 SUPPL-55 REMS-Modified Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/020616Orig1s055ltr.pdf
06/26/2015 SUPPL-54 REMS-Modified Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/020616Orig1s054ltr.pdf
08/19/2014 SUPPL-53 REMS-Modified Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/020616Orig1s053ltr.pdf
04/14/2014 SUPPL-52 Manufacturing (CMC)

Label is not available on this site.

04/16/2014 SUPPL-51 Labeling-Medication Guide, Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020616s051lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/020616Orig1s051ltr.pdf
03/27/2013 SUPPL-48 Labeling-Container/Carton Labels Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/020616Orig1s048ltr.pdf
04/15/2013 SUPPL-47 REMS-Modified Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/020616Orig1s047ltr.pdf
01/14/2013 SUPPL-46 Manufacturing (CMC)

Label is not available on this site.

07/09/2012 SUPPL-44 Manufacturing (CMC) Label (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020616s036s044lbl.pdf
07/09/2012 SUPPL-41 REMS-Proposal Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020616s041lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020616Orig1s041ltr.pdf
07/09/2012 SUPPL-36 Labeling-Package Insert

Label is not available on this site.

01/31/2008 SUPPL-28 Labeling-Container/Carton Labels, Labeling-Package Insert

Label is not available on this site.

04/20/2007 SUPPL-25 Labeling-Container/Carton Labels, Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020616s025lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/020616s025ltr.pdf
10/27/2006 SUPPL-22 Labeling-Container/Carton Labels, Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020616s022lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020616s022ltr.pdf
02/27/2007 SUPPL-21 Labeling Label (PDF)
Letter (PDF)
Review (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020616s017s021lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/020616s017, s021ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2007/020616_S021_KADIAN.pdf
02/27/2007 SUPPL-17 Manufacturing (CMC)-Formulation Label (PDF)
Letter (PDF)
Review (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020616s017s021lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/020616s017, s021ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2007/020616_S017_KADIAN.pdf
09/28/2005 SUPPL-10 Manufacturing (CMC)-Packaging Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020616s010lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/020616s010ltr.pdf
03/28/2002 SUPPL-9 Manufacturing (CMC)-Control

Label is not available on this site.

12/18/2001 SUPPL-8 Manufacturing (CMC)-Control

Label is not available on this site.

12/21/2001 SUPPL-7 Manufacturing (CMC)-Control

Label is not available on this site.

02/08/2001 SUPPL-6 Manufacturing (CMC)

Label is not available on this site.

02/28/2000 SUPPL-5 Manufacturing (CMC)-Formulation

Label is not available on this site.

03/09/2001 SUPPL-4 Manufacturing (CMC)-Control

Label is not available on this site.

07/16/1999 SUPPL-3 Labeling

Label is not available on this site.

04/08/1998 SUPPL-2 Manufacturing (CMC)-Packaging

Label is not available on this site.

07/29/1997 SUPPL-1 Labeling Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/97/020616S1_Kadian.pdf
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
10/07/2019 SUPPL-63 Labeling-Medication Guide Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/020616s063lbl.pdf
10/07/2019 SUPPL-63 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/020616s063lbl.pdf
09/18/2018 SUPPL-62 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/020616s061s062lbl.pdf
09/18/2018 SUPPL-61 REMS - MODIFIED - D-N-A Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/020616s061s062lbl.pdf
12/16/2016 SUPPL-57 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020616s057lbl.pdf
12/16/2016 SUPPL-57 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020616s057lbl.pdf
04/16/2014 SUPPL-51 Labeling-Medication Guide Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020616s051lbl.pdf
04/16/2014 SUPPL-51 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020616s051lbl.pdf
07/09/2012 SUPPL-44 Manufacturing (CMC) Label (PDF) This supplement type does not usually require new labeling. https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020616s036s044lbl.pdf
07/09/2012 SUPPL-41 REMS-Proposal Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020616s041lbl.pdf
04/20/2007 SUPPL-25 Labeling-Container/Carton Labels Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020616s025lbl.pdf
04/20/2007 SUPPL-25 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020616s025lbl.pdf
02/27/2007 SUPPL-21 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020616s017s021lbl.pdf
02/27/2007 SUPPL-17 Manufacturing (CMC)-Formulation Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020616s017s021lbl.pdf
10/27/2006 SUPPL-22 Labeling-Container/Carton Labels Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020616s022lbl.pdf
10/27/2006 SUPPL-22 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020616s022lbl.pdf
09/28/2005 SUPPL-10 Manufacturing (CMC)-Packaging Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020616s010lbl.pdf

KADIAN

CAPSULE, EXTENDED RELEASE;ORAL; 20MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
KADIAN MORPHINE SULFATE 20MG CAPSULE, EXTENDED RELEASE;ORAL Prescription Yes AB 020616 ALLERGAN
MORPHINE SULFATE MORPHINE SULFATE 20MG CAPSULE, EXTENDED RELEASE;ORAL Prescription No AB 200411 IMPAX LABS INC
MORPHINE SULFATE MORPHINE SULFATE 20MG CAPSULE, EXTENDED RELEASE;ORAL Prescription No AB 200812 PAR PHARM INC
MORPHINE SULFATE MORPHINE SULFATE 20MG CAPSULE, EXTENDED RELEASE;ORAL Prescription No AB 202718 TEVA PHARMS USA
MORPHINE SULFATE MORPHINE SULFATE 20MG CAPSULE, EXTENDED RELEASE;ORAL Prescription No AB 202104 UPSHER SMITH LABS

CAPSULE, EXTENDED RELEASE;ORAL; 50MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
KADIAN MORPHINE SULFATE 50MG CAPSULE, EXTENDED RELEASE;ORAL Prescription Yes AB 020616 ALLERGAN
MORPHINE SULFATE MORPHINE SULFATE 50MG CAPSULE, EXTENDED RELEASE;ORAL Prescription No AB 200411 IMPAX LABS INC
MORPHINE SULFATE MORPHINE SULFATE 50MG CAPSULE, EXTENDED RELEASE;ORAL Prescription No AB 200812 PAR PHARM INC
MORPHINE SULFATE MORPHINE SULFATE 50MG CAPSULE, EXTENDED RELEASE;ORAL Prescription No AB 202718 TEVA PHARMS USA
MORPHINE SULFATE MORPHINE SULFATE 50MG CAPSULE, EXTENDED RELEASE;ORAL Prescription No AB 202104 UPSHER SMITH LABS

CAPSULE, EXTENDED RELEASE;ORAL; 100MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
KADIAN MORPHINE SULFATE 100MG CAPSULE, EXTENDED RELEASE;ORAL Prescription Yes AB 020616 ALLERGAN
MORPHINE SULFATE MORPHINE SULFATE 100MG CAPSULE, EXTENDED RELEASE;ORAL Prescription No AB 200411 IMPAX LABS INC
MORPHINE SULFATE MORPHINE SULFATE 100MG CAPSULE, EXTENDED RELEASE;ORAL Prescription No AB 200812 PAR PHARM INC
MORPHINE SULFATE MORPHINE SULFATE 100MG CAPSULE, EXTENDED RELEASE;ORAL Prescription No AB 202718 TEVA PHARMS USA
MORPHINE SULFATE MORPHINE SULFATE 100MG CAPSULE, EXTENDED RELEASE;ORAL Prescription No AB 202104 UPSHER SMITH LABS

CAPSULE, EXTENDED RELEASE;ORAL; 30MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
KADIAN MORPHINE SULFATE 30MG CAPSULE, EXTENDED RELEASE;ORAL Prescription Yes AB 020616 ALLERGAN
MORPHINE SULFATE MORPHINE SULFATE 30MG CAPSULE, EXTENDED RELEASE;ORAL Prescription No AB 200411 IMPAX LABS INC
MORPHINE SULFATE MORPHINE SULFATE 30MG CAPSULE, EXTENDED RELEASE;ORAL Prescription No AB 200812 PAR PHARM INC
MORPHINE SULFATE MORPHINE SULFATE 30MG CAPSULE, EXTENDED RELEASE;ORAL Prescription No AB 202718 TEVA PHARMS USA
MORPHINE SULFATE MORPHINE SULFATE 30MG CAPSULE, EXTENDED RELEASE;ORAL Prescription No AB 202104 UPSHER SMITH LABS

CAPSULE, EXTENDED RELEASE;ORAL; 60MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
KADIAN MORPHINE SULFATE 60MG CAPSULE, EXTENDED RELEASE;ORAL Prescription Yes AB 020616 ALLERGAN
MORPHINE SULFATE MORPHINE SULFATE 60MG CAPSULE, EXTENDED RELEASE;ORAL Prescription No AB 200411 IMPAX LABS INC
MORPHINE SULFATE MORPHINE SULFATE 60MG CAPSULE, EXTENDED RELEASE;ORAL Prescription No AB 200812 PAR PHARM INC
MORPHINE SULFATE MORPHINE SULFATE 60MG CAPSULE, EXTENDED RELEASE;ORAL Prescription No AB 202718 TEVA PHARMS USA
MORPHINE SULFATE MORPHINE SULFATE 60MG CAPSULE, EXTENDED RELEASE;ORAL Prescription No AB 202104 UPSHER SMITH LABS

CAPSULE, EXTENDED RELEASE;ORAL; 80MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
KADIAN MORPHINE SULFATE 80MG CAPSULE, EXTENDED RELEASE;ORAL Prescription Yes AB 020616 ALLERGAN
MORPHINE SULFATE MORPHINE SULFATE 80MG CAPSULE, EXTENDED RELEASE;ORAL Prescription No AB 200411 IMPAX LABS INC
MORPHINE SULFATE MORPHINE SULFATE 80MG CAPSULE, EXTENDED RELEASE;ORAL Prescription No AB 200812 PAR PHARM INC
MORPHINE SULFATE MORPHINE SULFATE 80MG CAPSULE, EXTENDED RELEASE;ORAL Prescription No AB 202718 TEVA PHARMS USA
MORPHINE SULFATE MORPHINE SULFATE 80MG CAPSULE, EXTENDED RELEASE;ORAL Prescription No AB 202104 UPSHER SMITH LABS

CAPSULE, EXTENDED RELEASE;ORAL; 10MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
KADIAN MORPHINE SULFATE 10MG CAPSULE, EXTENDED RELEASE;ORAL Prescription Yes AB 020616 ALLERGAN
MORPHINE SULFATE MORPHINE SULFATE 10MG CAPSULE, EXTENDED RELEASE;ORAL Prescription No AB 202104 UPSHER SMITH LABS

CAPSULE, EXTENDED RELEASE;ORAL; 40MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
KADIAN MORPHINE SULFATE 40MG CAPSULE, EXTENDED RELEASE;ORAL Prescription Yes AB 020616 ALLERGAN
MORPHINE SULFATE MORPHINE SULFATE 40MG CAPSULE, EXTENDED RELEASE;ORAL Prescription No AB 202718 TEVA PHARMS USA

CAPSULE, EXTENDED RELEASE;ORAL; 70MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
KADIAN MORPHINE SULFATE 70MG CAPSULE, EXTENDED RELEASE;ORAL Prescription Yes AB 020616 ALLERGAN
MORPHINE SULFATE MORPHINE SULFATE 70MG CAPSULE, EXTENDED RELEASE;ORAL Prescription No AB 202718 TEVA PHARMS USA

Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players.
Language Assistance Available: Español | 繁體中文 | Tiếng Việt | 한국어 | Tagalog | Русский | العربية | Kreyòl Ayisyen | Français | Polski | Português | Italiano | Deutsch | 日本語 | فارسی | English