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Abbreviated New Drug Application (ANDA): 203559
Company: EDENBRIDGE PHARMS
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
PREDNISOLONE SODIUM PHOSPHATE PREDNISOLONE SODIUM PHOSPHATE EQ 10MG BASE/5ML SOLUTION;ORAL Prescription AA No No
PREDNISOLONE SODIUM PHOSPHATE PREDNISOLONE SODIUM PHOSPHATE EQ 20MG 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
12/20/2016 ORIG-1 Approval Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/203559Orig1s000ltr.pdf

PREDNISOLONE SODIUM PHOSPHATE

SOLUTION;ORAL; EQ 10MG 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 10MG BASE/5ML SOLUTION;ORAL Prescription No AA 203559 EDENBRIDGE PHARMS
PREDNISOLONE SODIUM PHOSPHATE PREDNISOLONE SODIUM PHOSPHATE EQ 10MG BASE/5ML SOLUTION;ORAL Prescription No AA 078465 PHARM ASSOC

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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