Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 212262
Company: PRAXGEN

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
METHYLPREDNISOLONE METHYLPREDNISOLONE 4MG TABLET;ORAL Prescription AB No No

Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
06/27/2019 ORIG-1 Approval STANDARD

Label is not available on this site.

METHYLPREDNISOLONE

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 040189 JUBILANT CADISTA
METHYLPREDNISOLONE METHYLPREDNISOLONE 4MG TABLET;ORAL Prescription No AB 212262 PRAXGEN
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 040183 VINTAGE PHARMS
METHYLPREDNISOLONE METHYLPREDNISOLONE 4MG TABLET;ORAL Prescription No AB 040232 WATSON LABS
METHYLPREDNISOLONE METHYLPREDNISOLONE 4MG TABLET;ORAL Prescription No AB 206751 ZYDUS PHARMS

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