Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

New Drug Application (NDA): 022207
Company: HIKMA

• Medication Guide

• REMS

• Summary Review

Products on NDA 22207

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
MORPHINE SULFATE	MORPHINE SULFATE	15MG	TABLET;ORAL	Prescription	AB	Yes	No
MORPHINE SULFATE	MORPHINE SULFATE	30MG	TABLET;ORAL	Prescription	AB	Yes	Yes

Labels for NDA 022207

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
12/15/2023	SUPPL-11	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/022207s011lbl.pdf
06/02/2021	SUPPL-5	Efficacy-Pediatric	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/022207s005lbl.pdf
03/04/2021	SUPPL-10	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/022207s010lbl.pdf
10/07/2019	SUPPL-9	Labeling-Medication Guide	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/022207s009lbl.pdf
10/07/2019	SUPPL-9	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/022207s009lbl.pdf
09/18/2018	SUPPL-8	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/022207s007s008lbl.pdf
09/18/2018	SUPPL-7	REMS - PROPOSAL - D-N-A	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/022207s007s008lbl.pdf
12/16/2016	SUPPL-6	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/022207s006lbl.pdf
12/16/2016	SUPPL-6	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/022207s006lbl.pdf
12/16/2016	SUPPL-6	Labeling-Medication Guide	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/022207s006lbl.pdf
01/23/2012	SUPPL-4	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022207s004lbl.pdf
03/17/2008	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/022195,022207lbl.pdf