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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

Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
10/24/1957 ORIG-1 Approval Type 1 - New Molecular Entity STANDARD

Label is not available on this site.
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
12/19/2023 SUPPL-81 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/011153s081lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/011153Orig1s081ltr.pdf
08/26/2019 SUPPL-77 Manufacturing (CMC)-Facility Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/011153Orig1s077lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/011153Orig1s077ltr.pdf
07/24/2018 SUPPL-75 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/011153Orig1s077lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/011153Orig1s075Ltr.pdf
07/18/2013 SUPPL-71 Manufacturing (CMC)

Label is not available on this site.
10/25/2002 SUPPL-59 Manufacturing (CMC)

Label is not available on this site.
12/01/1999 SUPPL-58 Manufacturing (CMC)-Packaging

Label is not available on this site.
01/28/1993 SUPPL-52 Manufacturing (CMC)

Label is not available on this site.
12/28/1993 SUPPL-51 Labeling Label (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/pre96/011153s051lbl.pdf
01/05/1989 SUPPL-49 Manufacturing (CMC)

Label is not available on this site.
02/24/1987 SUPPL-47 Manufacturing (CMC)-Control

Label is not available on this site.
03/09/1983 SUPPL-46 Labeling

Label is not available on this site.
10/08/1980 SUPPL-44 Manufacturing (CMC)-Formulation

Label is not available on this site.
04/14/1980 SUPPL-43 Labeling

Label is not available on this site.
04/05/1979 SUPPL-42 Manufacturing (CMC)

Label is not available on this site.
04/11/1978 SUPPL-41 Labeling

Label is not available on this site.
05/30/1979 SUPPL-40 Manufacturing (CMC)-Formulation

Label is not available on this site.
04/05/1979 SUPPL-39 Manufacturing (CMC)-Formulation

Label is not available on this site.
09/10/1976 SUPPL-37 Manufacturing (CMC)-Control

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert		 Note Url
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

MEDROL

TABLET;ORAL; 4MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
MEDROL METHYLPREDNISOLONE 4MG TABLET;ORAL Prescription Yes AB 011153 PFIZER
METHYLPREDNISOLONE METHYLPREDNISOLONE 4MG TABLET;ORAL Prescription No AB 040183 ENDO OPERATIONS
METHYLPREDNISOLONE METHYLPREDNISOLONE 4MG TABLET;ORAL Prescription No AB 040189 JUBILANT CADISTA
METHYLPREDNISOLONE METHYLPREDNISOLONE 4MG TABLET;ORAL Prescription No AB 040194 SANDOZ
METHYLPREDNISOLONE METHYLPREDNISOLONE 4MG TABLET;ORAL Prescription No AB 204072 TIANJIN TIANYAO
METHYLPREDNISOLONE METHYLPREDNISOLONE 4MG TABLET;ORAL Prescription No AB 040232 WATSON LABS
METHYLPREDNISOLONE METHYLPREDNISOLONE 4MG TABLET;ORAL Prescription No AB 206751 ZYDUS PHARMS

TABLET;ORAL; 2MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
MEDROL METHYLPREDNISOLONE 2MG TABLET;ORAL Prescription Yes AB 011153 PFIZER

TABLET;ORAL; 16MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
MEDROL METHYLPREDNISOLONE 16MG TABLET;ORAL Prescription Yes AB 011153 PFIZER
METHYLPREDNISOLONE METHYLPREDNISOLONE 16MG TABLET;ORAL Prescription No AB 040189 JUBILANT CADISTA
METHYLPREDNISOLONE METHYLPREDNISOLONE 16MG TABLET;ORAL Prescription No AB 206751 ZYDUS PHARMS

TABLET;ORAL; 8MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
MEDROL METHYLPREDNISOLONE 8MG TABLET;ORAL Prescription Yes AB 011153 PFIZER
METHYLPREDNISOLONE METHYLPREDNISOLONE 8MG TABLET;ORAL Prescription No AB 040189 JUBILANT CADISTA
METHYLPREDNISOLONE METHYLPREDNISOLONE 8MG TABLET;ORAL Prescription No AB 206751 ZYDUS PHARMS

TABLET;ORAL; 32MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
MEDROL METHYLPREDNISOLONE 32MG TABLET;ORAL Prescription Yes AB 011153 PFIZER
METHYLPREDNISOLONE METHYLPREDNISOLONE 32MG TABLET;ORAL Prescription No AB 040189 JUBILANT CADISTA
METHYLPREDNISOLONE METHYLPREDNISOLONE 32MG TABLET;ORAL Prescription No AB 206751 ZYDUS PHARMS
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