Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 075042
Company: TARO
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
HYDROCORTISONE VALERATE HYDROCORTISONE VALERATE 0.2% CREAM;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/anda/98/75-042_prntlbl.PDF https://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/75042ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/anda/98/075042_hydrocortisone_toc.cfm
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
08/08/2003 SUPPL-6 Labeling

Label is not available on this site.

07/15/2002 SUPPL-4 Manufacturing (CMC)-Facility

Label is not available on this site.

09/16/1999 SUPPL-3 Manufacturing (CMC)

Label is not available on this site.

02/11/1999 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/anda/98/75-042_prntlbl.PDF

HYDROCORTISONE VALERATE

CREAM;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% CREAM;TOPICAL Prescription No AB 211129 GLENMARK PHARMS LTD
HYDROCORTISONE VALERATE HYDROCORTISONE VALERATE 0.2% CREAM;TOPICAL Prescription No AB 210307 LUPIN LTD
HYDROCORTISONE VALERATE HYDROCORTISONE VALERATE 0.2% CREAM;TOPICAL Prescription No AB 075666 PERRIGO ISRAEL
HYDROCORTISONE VALERATE HYDROCORTISONE VALERATE 0.2% CREAM;TOPICAL Prescription No AB 075042 TARO

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