Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 075988
Company: CHARTWELL RX

Products on ANDA 075988

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

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 075988

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.

Therapeutic Equivalents for ANDA 075988

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	075988	CHARTWELL RX