Drugs@FDA: FDA Approved Drug Products

Home | Previous Page

New Drug Application (NDA): 018565
Company: WEST-WARD PHARMS INT
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
DURAMORPH PF MORPHINE SULFATE 0.5MG/ML INJECTABLE;INJECTION Prescription AP Yes Yes
DURAMORPH PF MORPHINE SULFATE 1MG/ML INJECTABLE;INJECTION Prescription AP Yes Yes
INFUMORPH MORPHINE SULFATE 10MG/ML INJECTABLE;INJECTION Prescription AP Yes Yes
INFUMORPH MORPHINE SULFATE 25MG/ML INJECTABLE;INJECTION Prescription AP Yes Yes
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
09/18/1984 ORIG-1 Approval Type 3 - New Dosage Form PRIORITY; Orphan

Label is not available on this site.

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
12/16/2016 SUPPL-22 Labeling-Package Insert, Labeling-Package Insert Label (PDF)
Label (PDF)
Letter (PDF)
Letter (PDF)
DURAMORPH & INFUMORPH have separate letters and labels https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/018565s022lbl_Duramorph.pdf https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/018565s022lbl_Infumorph.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/018565Orig1s022ltr_Duramorph.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/018565Orig1s022ltr_Infumorph.pdf
06/06/2016 SUPPL-21 Manufacturing (CMC)

Label is not available on this site.

10/01/2010 SUPPL-20 Labeling-Package Insert Label (PDF)
Letter (PDF)
Label for DURAMORPH https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/018565s020lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/018565s020ltr.pdf
06/06/2005 SUPPL-14 Labeling Label (PDF)
Letter (PDF)
Label for DURAMORPH https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/018565s014lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/018565s014ltr.pdf
05/27/2004 SUPPL-12 Labeling Label (PDF)
Letter (PDF)
Label for INFUMORPH https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/018565s012lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/18565slr012ltr.pdf
06/26/2003 SUPPL-10 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/18565slr010ltr.pdf
12/07/2001 SUPPL-9 Labeling

Label is not available on this site.

06/14/1999 SUPPL-8 Manufacturing (CMC)-Control

Label is not available on this site.

04/17/1998 SUPPL-7 Manufacturing (CMC)-Control

Label is not available on this site.

02/12/1997 SUPPL-6 Manufacturing (CMC)-Control

Label is not available on this site.

04/28/1994 SUPPL-5 Labeling

Label is not available on this site.

05/03/1989 SUPPL-4 Labeling

Label is not available on this site.

07/19/1991 SUPPL-3 Labeling

Label is not available on this site.

07/19/1991 SUPPL-2 Manufacturing (CMC)-Control

Label is not available on this site.

08/22/1985 SUPPL-1 Labeling

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
12/16/2016 SUPPL-22 Labeling-Package Insert Label (PDF) DURAMORPH & INFUMORPH have separate letters and labels https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/018565s022lbl_Duramorph.pdf
12/16/2016 SUPPL-22 Labeling-Package Insert Label (PDF) DURAMORPH & INFUMORPH have separate letters and labels https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/018565s022lbl_Duramorph.pdf
12/16/2016 SUPPL-22 Labeling-Package Insert Label (PDF) DURAMORPH & INFUMORPH have separate letters and labels https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/018565s022lbl_Infumorph.pdf
12/16/2016 SUPPL-22 Labeling-Package Insert Label (PDF) DURAMORPH & INFUMORPH have separate letters and labels https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/018565s022lbl_Infumorph.pdf
10/01/2010 SUPPL-20 Labeling-Package Insert Label (PDF) Label for DURAMORPH https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/018565s020lbl.pdf
06/06/2005 SUPPL-14 Labeling Label (PDF) Label for DURAMORPH https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/018565s014lbl.pdf
05/27/2004 SUPPL-12 Labeling Label (PDF) Label for INFUMORPH https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/018565s012lbl.pdf

DURAMORPH PF

INJECTABLE;INJECTION; 0.5MG/ML
TE Code = AP

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
DURAMORPH PF MORPHINE SULFATE 0.5MG/ML INJECTABLE;INJECTION Prescription Yes AP 018565 WEST-WARD PHARMS INT
MORPHINE SULFATE MORPHINE SULFATE 0.5MG/ML INJECTABLE;INJECTION Prescription No AP 071849 HOSPIRA
MORPHINE SULFATE MORPHINE SULFATE 0.5MG/ML INJECTABLE;INJECTION Prescription No AP 073509 HOSPIRA

INJECTABLE;INJECTION; 1MG/ML
TE Code = AP

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
DURAMORPH PF MORPHINE SULFATE 1MG/ML INJECTABLE;INJECTION Prescription Yes AP 018565 WEST-WARD PHARMS INT
MORPHINE SULFATE MORPHINE SULFATE 1MG/ML INJECTABLE;INJECTION Prescription No AP 071850 HOSPIRA
MORPHINE SULFATE MORPHINE SULFATE 1MG/ML INJECTABLE;INJECTION Prescription No AP 073510 HOSPIRA
MORPHINE SULFATE MORPHINE SULFATE 1MG/ML INJECTABLE;INJECTION Prescription Yes AP 019916 ICU MEDICAL INC

INFUMORPH

INJECTABLE;INJECTION; 10MG/ML
TE Code = AP

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
INFUMORPH MORPHINE SULFATE 10MG/ML INJECTABLE;INJECTION Prescription Yes AP 018565 WEST-WARD PHARMS INT
MITIGO MORPHINE SULFATE 10MG/ML INJECTABLE;INJECTION Prescription No AP 204393 PIRAMAL CRITICAL
MORPHINE SULFATE MORPHINE SULFATE 10MG/ML INJECTABLE;INJECTION Prescription No AP 205758 EUROHLTH INTL SARL
MORPHINE SULFATE MORPHINE SULFATE 10MG/ML INJECTABLE;INJECTION Prescription Yes AP 202515 HOSPIRA INC

INJECTABLE;INJECTION; 25MG/ML
TE Code = AP

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
INFUMORPH MORPHINE SULFATE 25MG/ML INJECTABLE;INJECTION Prescription Yes AP 018565 WEST-WARD PHARMS INT
MITIGO MORPHINE SULFATE 25MG/ML INJECTABLE;INJECTION Prescription No AP 204393 PIRAMAL CRITICAL

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