Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 211750
Company: GLENMARK PHARMS LTD
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 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
12/14/2018 ORIG-1 Approval STANDARD Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/211750Orig1s000ltr.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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