Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 209097
Company: LUPIN LTD
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
METHYLPREDNISOLONE METHYLPREDNISOLONE 2MG TABLET;ORAL Prescription AB No No
METHYLPREDNISOLONE METHYLPREDNISOLONE 4MG TABLET;ORAL Prescription AB No No
METHYLPREDNISOLONE METHYLPREDNISOLONE 8MG TABLET;ORAL Prescription AB No No
METHYLPREDNISOLONE METHYLPREDNISOLONE 16MG TABLET;ORAL Prescription AB No No
METHYLPREDNISOLONE METHYLPREDNISOLONE 32MG 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
02/22/2019 ORIG-1 Approval STANDARD

Label is not available on this site.

METHYLPREDNISOLONE

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 PHARMACIA AND UPJOHN
METHYLPREDNISOLONE METHYLPREDNISOLONE 2MG TABLET;ORAL Prescription No AB 209097 LUPIN LTD

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 PHARMACIA AND UPJOHN
METHYLPREDNISOLONE METHYLPREDNISOLONE 4MG TABLET;ORAL Prescription No AB 088497 DURAMED PHARMS BARR
METHYLPREDNISOLONE METHYLPREDNISOLONE 4MG TABLET;ORAL Prescription No AB 040189 JUBILANT CADISTA
METHYLPREDNISOLONE METHYLPREDNISOLONE 4MG TABLET;ORAL Prescription No AB 209097 LUPIN LTD
METHYLPREDNISOLONE METHYLPREDNISOLONE 4MG TABLET;ORAL Prescription No AB 210985 RICONPHARMA LLC
METHYLPREDNISOLONE METHYLPREDNISOLONE 4MG TABLET;ORAL Prescription No AB 040194 SANDOZ
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

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 PHARMACIA AND UPJOHN
METHYLPREDNISOLONE METHYLPREDNISOLONE 8MG TABLET;ORAL Prescription No AB 040189 JUBILANT CADISTA
METHYLPREDNISOLONE METHYLPREDNISOLONE 8MG TABLET;ORAL Prescription No AB 209097 LUPIN LTD
METHYLPREDNISOLONE METHYLPREDNISOLONE 8MG TABLET;ORAL Prescription No AB 206751 ZYDUS PHARMS

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 PHARMACIA AND UPJOHN
METHYLPREDNISOLONE METHYLPREDNISOLONE 16MG TABLET;ORAL Prescription No AB 040189 JUBILANT CADISTA
METHYLPREDNISOLONE METHYLPREDNISOLONE 16MG TABLET;ORAL Prescription No AB 209097 LUPIN LTD
METHYLPREDNISOLONE METHYLPREDNISOLONE 16MG 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 PHARMACIA AND UPJOHN
METHYLPREDNISOLONE METHYLPREDNISOLONE 32MG TABLET;ORAL Prescription No AB 040189 JUBILANT CADISTA
METHYLPREDNISOLONE METHYLPREDNISOLONE 32MG TABLET;ORAL Prescription No AB 209097 LUPIN LTD
METHYLPREDNISOLONE METHYLPREDNISOLONE 32MG TABLET;ORAL Prescription No AB 206751 ZYDUS PHARMS

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