Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 075043
Company: TARO
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
HYDROCORTISONE VALERATE HYDROCORTISONE VALERATE 0.2% OINTMENT;TOPICAL Prescription AB No Yes
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
08/25/1998 ORIG-1 Approval Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/nda/98/75043_Hydrocortisone%20Valerate_prntlbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/75043ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/98/75043_Hydrocortisone.cfm
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
08/04/2003 SUPPL-5 Labeling

Label is not available on this site.

07/29/2002 SUPPL-3 Manufacturing (CMC)-Facility

Label is not available on this site.

04/27/2001 SUPPL-2 Manufacturing (CMC)

Label is not available on this site.

12/21/1998 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
08/25/1998 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/nda/98/75043_Hydrocortisone%20Valerate_prntlbl.pdf

HYDROCORTISONE VALERATE

OINTMENT;TOPICAL; 0.2%
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
HYDROCORTISONE VALERATE HYDROCORTISONE VALERATE 0.2% OINTMENT;TOPICAL Prescription No AB 211750 GLENMARK PHARMS LTD
HYDROCORTISONE VALERATE HYDROCORTISONE VALERATE 0.2% OINTMENT;TOPICAL Prescription No AB 075043 TARO

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