Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 080442
Company: BAUSCH

Products on ANDA 080442

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
NUTRACORT	HYDROCORTISONE	0.5%	CREAM;TOPICAL	Discontinued	None	No	No
NUTRACORT	HYDROCORTISONE	1%	CREAM;TOPICAL	Discontinued	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 080442

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
04/04/1972	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
04/25/1994	SUPPL-47	Labeling		Label is not available on this site.
02/01/1991	SUPPL-46	Labeling		Label is not available on this site.
11/15/1985	SUPPL-44	Manufacturing (CMC)		Label is not available on this site.
12/23/1985	SUPPL-42	Manufacturing (CMC)		Label is not available on this site.
12/23/1985	SUPPL-41	Manufacturing (CMC)		Label is not available on this site.
03/26/1985	SUPPL-40	Manufacturing (CMC)		Label is not available on this site.
03/26/1985	SUPPL-38	Manufacturing (CMC)		Label is not available on this site.
07/18/1984	SUPPL-35	Manufacturing (CMC)		Label is not available on this site.
07/18/1984	SUPPL-34	Manufacturing (CMC)		Label is not available on this site.
12/04/1984	SUPPL-33	Manufacturing (CMC)		Label is not available on this site.
12/04/1984	SUPPL-31	Manufacturing (CMC)		Label is not available on this site.
12/04/1984	SUPPL-30	Manufacturing (CMC)		Label is not available on this site.
10/22/1982	SUPPL-28	Manufacturing (CMC)		Label is not available on this site.