Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 011856
Company: PHARMACIA AND UPJOHN

Products on NDA 11856

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
SOLU-MEDROL	METHYLPREDNISOLONE SODIUM SUCCINATE	EQ 40MG BASE/VIAL	INJECTABLE;INJECTION	Prescription	AP	Yes	Yes
SOLU-MEDROL	METHYLPREDNISOLONE SODIUM SUCCINATE	EQ 125MG BASE/VIAL	INJECTABLE;INJECTION	Prescription	AP	Yes	Yes
SOLU-MEDROL	METHYLPREDNISOLONE SODIUM SUCCINATE	EQ 500MG BASE/VIAL	INJECTABLE;INJECTION	Prescription	AP	Yes	Yes
SOLU-MEDROL	METHYLPREDNISOLONE SODIUM SUCCINATE	EQ 1GM BASE/VIAL	INJECTABLE;INJECTION	Prescription	AP	Yes	Yes
SOLU-MEDROL	METHYLPREDNISOLONE SODIUM SUCCINATE	EQ 2GM BASE/VIAL	INJECTABLE;INJECTION	Prescription	AP	Yes	Yes

Labels for NDA 011856

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
12/20/2023	SUPPL-141	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/011856s141lbl.pdf
10/27/2021	SUPPL-139	Manufacturing (CMC)-Control	Label (PDF)	This supplement type does not usually require new labeling.	https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/011856s139lbl.pdf
05/27/2021	SUPPL-136	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/011856s136lbl.pdf
07/24/2018	SUPPL-133	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/011856s133lbl.pdf
03/28/2018	SUPPL-131	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/011856s131lbl.pdf
09/08/2016	SUPPL-126	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/011856s124and126lbl.pdf
09/08/2016	SUPPL-124	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/011856s124and126lbl.pdf
07/03/2014	SUPPL-123	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/011856s123lbl.pdf
10/20/2011	SUPPL-104	Labeling-Container/Carton Labels	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/011856s103s104lbl.pdf
10/20/2011	SUPPL-103	Manufacturing (CMC)	Label (PDF)	This supplement type does not usually require new labeling.	https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/011856s103s104lbl.pdf
06/24/2010	SUPPL-107	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/011856s107lbl.pdf