Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 020769
Company: PRECISION DERMAT
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
LOCOID LIPOCREAM HYDROCORTISONE BUTYRATE 0.1% CREAM;TOPICAL Prescription AB2 Yes 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
09/08/1997 ORIG-1 Approval Type 3 - New Dosage Form STANDARD Review

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/97/020769_locoid_toc.cfm
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
11/20/2014 SUPPL-14 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020769s014lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/020769Orig1s014ltr.pdf
09/04/2009 SUPPL-12 Labeling-Container/Carton Labels

Label is not available on this site.

10/19/2009 SUPPL-11 Efficacy-New Patient Population Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020769s011lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020769s011ltr.pdf
04/21/2006 SUPPL-9 Labeling-Package Insert, Labeling-Container/Carton Labels Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020769s009LTR.pdf
08/23/2004 SUPPL-3 Manufacturing (CMC) Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20769s003ltr.pdf
03/12/1998 SUPPL-1 Manufacturing (CMC)-Expiration Date

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
11/20/2014 SUPPL-14 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020769s014lbl.pdf
10/19/2009 SUPPL-11 Efficacy-New Patient Population Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020769s011lbl.pdf

LOCOID LIPOCREAM

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

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