Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 078988
Company: PHARM ASSOC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
PREDNISOLONE SODIUM PHOSPHATE PREDNISOLONE SODIUM PHOSPHATE EQ 20MG BASE/5ML SOLUTION;ORAL Prescription AA No 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
06/09/2008 ORIG-1 Approval

Label is not available on this site.

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
03/24/2010 SUPPL-5 Labeling-Package Insert

Label is not available on this site.

PREDNISOLONE SODIUM PHOSPHATE

SOLUTION;ORAL; EQ 20MG BASE/5ML
TE Code = AA

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
PREDNISOLONE SODIUM PHOSPHATE PREDNISOLONE SODIUM PHOSPHATE EQ 20MG BASE/5ML SOLUTION;ORAL Prescription No AA 203559 EDENBRIDGE PHARMS
PREDNISOLONE SODIUM PHOSPHATE PREDNISOLONE SODIUM PHOSPHATE EQ 20MG BASE/5ML SOLUTION;ORAL Prescription No AA 078988 PHARM ASSOC

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