Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 202179
Company: MYLAN PHARMS INC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
PREDNISOLONE SODIUM PHOSPHATE PREDNISOLONE SODIUM PHOSPHATE EQ 10MG BASE TABLET, ORALLY DISINTEGRATING;ORAL Prescription AB No No
PREDNISOLONE SODIUM PHOSPHATE PREDNISOLONE SODIUM PHOSPHATE EQ 15MG BASE TABLET, ORALLY DISINTEGRATING;ORAL Prescription AB No No
PREDNISOLONE SODIUM PHOSPHATE PREDNISOLONE SODIUM PHOSPHATE EQ 30MG BASE TABLET, ORALLY DISINTEGRATING;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
04/10/2013 ORIG-1 Approval Not Applicable

Label is not available on this site.

PREDNISOLONE SODIUM PHOSPHATE

TABLET, ORALLY DISINTEGRATING;ORAL; EQ 10MG BASE
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
ORAPRED ODT PREDNISOLONE SODIUM PHOSPHATE EQ 10MG BASE TABLET, ORALLY DISINTEGRATING;ORAL Prescription Yes AB 021959 CONCORDIA PHARMS INC
PREDNISOLONE SODIUM PHOSPHATE PREDNISOLONE SODIUM PHOSPHATE EQ 10MG BASE TABLET, ORALLY DISINTEGRATING;ORAL Prescription No AB 202179 MYLAN PHARMS INC

TABLET, ORALLY DISINTEGRATING;ORAL; EQ 15MG BASE
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
ORAPRED ODT PREDNISOLONE SODIUM PHOSPHATE EQ 15MG BASE TABLET, ORALLY DISINTEGRATING;ORAL Prescription Yes AB 021959 CONCORDIA PHARMS INC
PREDNISOLONE SODIUM PHOSPHATE PREDNISOLONE SODIUM PHOSPHATE EQ 15MG BASE TABLET, ORALLY DISINTEGRATING;ORAL Prescription No AB 202179 MYLAN PHARMS INC

TABLET, ORALLY DISINTEGRATING;ORAL; EQ 30MG BASE
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
ORAPRED ODT PREDNISOLONE SODIUM PHOSPHATE EQ 30MG BASE TABLET, ORALLY DISINTEGRATING;ORAL Prescription Yes AB 021959 CONCORDIA PHARMS INC
PREDNISOLONE SODIUM PHOSPHATE PREDNISOLONE SODIUM PHOSPHATE EQ 30MG BASE TABLET, ORALLY DISINTEGRATING;ORAL Prescription No AB 202179 MYLAN PHARMS INC

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