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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 076913
Company: PHARM ASSOC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
PREDNISOLONE SODIUM PHOSPHATE PREDNISOLONE SODIUM PHOSPHATE EQ 15MG BASE/5ML SOLUTION;ORAL Prescription AA 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
04/25/2005 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
04/16/2010 SUPPL-6 Labeling-Package Insert

Label is not available on this site.

06/02/2009 SUPPL-4 Labeling

Label is not available on this site.

10/05/2007 SUPPL-2 Manufacturing (CMC)-Control

Label is not available on this site.

PREDNISOLONE SODIUM PHOSPHATE

SOLUTION;ORAL; EQ 15MG 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 15MG BASE/5ML SOLUTION;ORAL Prescription No AA 076913 PHARM ASSOC
PREDNISOLONE SODIUM PHOSPHATE PREDNISOLONE SODIUM PHOSPHATE EQ 15MG BASE/5ML SOLUTION;ORAL Prescription No AA 076895 WOCKHARDT BIO AG
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