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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 075988
Company: CHARTWELL RX
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
PREDNISOLONE SODIUM PHOSPHATE PREDNISOLONE SODIUM PHOSPHATE EQ 5MG 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
05/25/2004 ORIG-1 Approval Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/075988_ORIGINAL APPROVAL_PACKAGE.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
03/05/2020 SUPPL-6 Labeling-Package Insert

Label is not available on this site.

06/09/2005 SUPPL-3 Labeling

Label is not available on this site.

PREDNISOLONE SODIUM PHOSPHATE

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

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
PEDIAPRED PREDNISOLONE SODIUM PHOSPHATE EQ 5MG BASE/5ML SOLUTION;ORAL Prescription Yes AA 019157 SETON PHARM
PREDNISOLONE SODIUM PHOSPHATE PREDNISOLONE SODIUM PHOSPHATE EQ 5MG BASE/5ML SOLUTION;ORAL Prescription No AA 075183 AKORN
PREDNISOLONE SODIUM PHOSPHATE PREDNISOLONE SODIUM PHOSPHATE EQ 5MG BASE/5ML SOLUTION;ORAL Prescription No AA 075988 CHARTWELL RX
PREDNISOLONE SODIUM PHOSPHATE PREDNISOLONE SODIUM PHOSPHATE EQ 5MG BASE/5ML SOLUTION;ORAL Prescription No AA 075099 WOCKHARDT BIO AG
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