Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 084275
Company: CHARTWELL MOLECULAR

Products on ANDA 084275

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
PREDNISONE	PREDNISONE	20MG	TABLET;ORAL	Prescription	BX	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 084275

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
06/27/1974	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
06/07/2024	SUPPL-12	Labeling-Package Insert, Labeling		Label is not available on this site.
06/07/2024	SUPPL-11	Labeling-Package Insert		Label is not available on this site.
03/25/1988	SUPPL-8	Labeling		Label is not available on this site.

Therapeutic Equivalents for ANDA 084275

PREDNISONE

There are no Therapeutic Equivalents.