Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 011153
Company: PFIZER

Products on NDA 11153

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
MEDROL	METHYLPREDNISOLONE	4MG	TABLET;ORAL	Prescription	AB	Yes	No
MEDROL	METHYLPREDNISOLONE	2MG	TABLET;ORAL	Prescription	AB	Yes	No
MEDROL	METHYLPREDNISOLONE	16MG	TABLET;ORAL	Prescription	AB	Yes	No
MEDROL	METHYLPREDNISOLONE	8MG	TABLET;ORAL	Prescription	AB	Yes	No
MEDROL	METHYLPREDNISOLONE	24MG	TABLET;ORAL	Discontinued	None	No	No
MEDROL	METHYLPREDNISOLONE	32MG	TABLET;ORAL	Prescription	AB	Yes	Yes

Labels for NDA 011153

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
11/04/2025	SUPPL-82	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/011153s082lbl.pdf
06/05/2024	SUPPL-83	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/011153s083lbl.pdf
12/19/2023	SUPPL-81	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/011153s081lbl.pdf
08/26/2019	SUPPL-77	Manufacturing (CMC)-Facility	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/011153Orig1s077lbl.pdf
07/24/2018	SUPPL-75	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/011153Orig1s077lbl.pdf
12/28/1993	SUPPL-51	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/pre96/011153s051lbl.pdf