Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 080354
Company: WATSON LABS

Products on ANDA 080354

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
PREDNISOLONE	PREDNISOLONE	5MG	TABLET;ORAL	Prescription	AB	Yes	Yes

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 080354

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
01/17/1972	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
06/05/2024	SUPPL-72	Labeling-Package Insert		Label is not available on this site.
09/16/2007	SUPPL-54	Manufacturing (CMC)		Label is not available on this site.
12/04/2001	SUPPL-48	Manufacturing (CMC)-Control		Label is not available on this site.
04/25/2001	SUPPL-46	Manufacturing (CMC)-Control		Label is not available on this site.
12/30/1998	SUPPL-44	Manufacturing (CMC)		Label is not available on this site.
03/30/1994	SUPPL-43	Labeling		Label is not available on this site.
03/26/1991	SUPPL-42	Labeling		Label is not available on this site.
01/28/1991	SUPPL-41	Manufacturing (CMC)		Label is not available on this site.
06/03/1985	SUPPL-34	Manufacturing (CMC)		Label is not available on this site.
06/03/1985	SUPPL-33	Manufacturing (CMC)		Label is not available on this site.
12/27/1983	SUPPL-31	Manufacturing (CMC)		Label is not available on this site.
11/22/1983	SUPPL-30	Manufacturing (CMC)		Label is not available on this site.

Therapeutic Equivalents for ANDA 080354

PREDNISOLONE

TABLET;ORAL; 5MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
PREDNISOLONE	PREDNISOLONE	5MG	TABLET;ORAL	Prescription	No	AB	215673	AUROBINDO PHARMA LTD
PREDNISOLONE	PREDNISOLONE	5MG	TABLET;ORAL	Prescription	Yes	AB	080354	WATSON LABS
PREDNISOLONE	PREDNISOLONE	5MG	TABLET;ORAL	Prescription	No	AB	218083	ZHEJIANG XIANJU