Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 080531
Company: CHARTWELL MOLECULAR

Products on ANDA 080531

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
PREDNISOLONE	PREDNISOLONE	5MG	TABLET;ORAL	Prescription	BX	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 080531

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
05/31/1974	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
10/02/2002	SUPPL-13	Manufacturing (CMC)-Control		Label is not available on this site.
09/25/2001	SUPPL-12	Manufacturing (CMC)-Control		Label is not available on this site.
09/25/2001	SUPPL-11	Manufacturing (CMC)-Packaging		Label is not available on this site.
09/25/2001	SUPPL-10	Labeling		Label is not available on this site.
09/25/2001	SUPPL-9	Manufacturing (CMC)-Formulation		Label is not available on this site.
08/10/2000	SUPPL-8	Manufacturing (CMC)-Facility		Label is not available on this site.
06/25/1992	SUPPL-7	Manufacturing (CMC)		Label is not available on this site.
05/23/1988	SUPPL-6	Labeling		Label is not available on this site.

Therapeutic Equivalents for ANDA 080531

PREDNISOLONE

There are no Therapeutic Equivalents.