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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 011153
Company: PFIZER
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
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
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
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