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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 040323
Company: CHARTWELL RX

Products on ANDA 040323

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
PREDNISOLONE	PREDNISOLONE	15MG/5ML	SOLUTION;ORAL	Prescription	AA	No	Yes

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 040323

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
05/13/1999	ORIG-1	Approval			Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/label/1999/40323lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/40323ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/anda/99/40323.html

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
06/05/2024	SUPPL-10	Labeling-Package Insert		Label is not available on this site.
01/22/2003	SUPPL-5	Labeling		Label is not available on this site.
01/30/2002	SUPPL-1	Manufacturing (CMC)-Facility		Label is not available on this site.

Labels for ANDA 040323

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
05/13/1999	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/1999/40323lbl.pdf

Therapeutic Equivalents for ANDA 040323

PREDNISOLONE

SOLUTION;ORAL; 15MG/5ML
TE Code = AA

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
PREDNISOLONE	PREDNISOLONE	15MG/5ML	SOLUTION;ORAL	Prescription	No	AA	040323	CHARTWELL RX
PREDNISOLONE	PREDNISOLONE	15MG/5ML	SOLUTION;ORAL	Prescription	No	AA	040775	LANNETT CO INC
PREDNISOLONE	PREDNISOLONE	15MG/5ML	SOLUTION;ORAL	Prescription	No	AA	040571	PHARM ASSOC
PREDNISOLONE	PREDNISOLONE	15MG/5ML	SOLUTION;ORAL	Prescription	No	AA	219509	TP ANDA HOLDINGS
PRELONE	PREDNISOLONE	15MG/5ML	SOLUTION;ORAL	Prescription	No	AA	089081	TEVA

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