Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 074489
Company: COSETTE

Products on ANDA 074489

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
HYDROCORTISONE VALERATE	HYDROCORTISONE VALERATE	0.2%	CREAM;TOPICAL	Discontinued	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 074489

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
08/12/1998	ORIG-1	Approval			Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/nda/98/74489_Hydrocortisone%20Valertate_prntlbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/74489ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/98/74489_Hydrocortisone.cfm

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
10/31/2001	SUPPL-6	Manufacturing (CMC)-Facility		Label is not available on this site.
10/31/2001	SUPPL-5	Manufacturing (CMC)-Facility		Label is not available on this site.
10/31/2001	SUPPL-4	Manufacturing (CMC)-Facility		Label is not available on this site.
01/23/2002	SUPPL-3	Manufacturing (CMC)-Facility		Label is not available on this site.
02/26/2001	SUPPL-2	Manufacturing (CMC)-Facility		Label is not available on this site.
03/23/1999	SUPPL-1	Manufacturing (CMC)		Label is not available on this site.

Labels for ANDA 074489

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
08/12/1998	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/nda/98/74489_Hydrocortisone%20Valertate_prntlbl.pdf