Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 211129
Company: GLENMARK PHARMS LTD
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 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
10/12/2018 ORIG-1 Approval STANDARD

Label is not available on this site.

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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