Drugs@FDA: FDA Approved Drug Products

Home | Previous Page

Abbreviated New Drug Application (ANDA): 202145
Company: GLENMARK GENERICS
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
HYDROCORTISONE BUTYRATE HYDROCORTISONE BUTYRATE 0.1% CREAM;TOPICAL Prescription AB2 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
09/27/2013 ORIG-1 Approval Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/202145Orig1lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/202145Orig1s000ltr.pdf
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
09/27/2013 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/202145Orig1lbl.pdf

HYDROCORTISONE BUTYRATE

CREAM;TOPICAL; 0.1%
TE Code = AB2

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
HYDROCORTISONE BUTYRATE HYDROCORTISONE BUTYRATE 0.1% CREAM;TOPICAL Prescription No AB2 205134 ACTAVIS MID ATLANTIC
HYDROCORTISONE BUTYRATE HYDROCORTISONE BUTYRATE 0.1% CREAM;TOPICAL Prescription No AB2 202145 GLENMARK GENERICS
LOCOID LIPOCREAM HYDROCORTISONE BUTYRATE 0.1% CREAM;TOPICAL Prescription Yes AB2 020769 PRECISION DERMAT

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