Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

Abbreviated New Drug Application (ANDA): 074489
Company: ACP NIMBLE
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
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.

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

Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players.
Language Assistance Available: Español | 繁體中文 | Tiếng Việt | 한국어 | Tagalog | Русский | العربية | Kreyòl Ayisyen | Français | Polski | Português | Italiano | Deutsch | 日本語 | فارسی | English