Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 018514
Company: PRECISION DERMAT
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
LOCOID HYDROCORTISONE BUTYRATE 0.1% CREAM;TOPICAL Prescription AB1 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
03/31/1982 ORIG-1 Approval Type 2 - New Active Ingredient STANDARD

Label is not available on this site.

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
10/30/2014 SUPPL-13 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/018514s013lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/018514Orig1s013ltr.pdf
01/08/2014 SUPPL-12 Manufacturing (CMC)

Label is not available on this site.

08/05/2013 SUPPL-11 Manufacturing (CMC)

Label is not available on this site.

12/12/2005 SUPPL-9 Manufacturing (CMC)-Control Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/018514s009ltr.pdf
05/22/2002 SUPPL-8 Manufacturing (CMC) Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/18514s008ltr.pdf
08/30/1996 SUPPL-7 Manufacturing (CMC)

Label is not available on this site.

02/24/1995 SUPPL-6 Manufacturing (CMC)

Label is not available on this site.

02/14/1996 SUPPL-5 Manufacturing (CMC)-Formulation

Label is not available on this site.

04/25/1995 SUPPL-4 Manufacturing (CMC)

Label is not available on this site.

02/20/1985 SUPPL-1 Manufacturing (CMC)-Control

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
10/30/2014 SUPPL-13 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/018514s013lbl.pdf

LOCOID

CREAM;TOPICAL; 0.1%
TE Code = AB1

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 AB1 076654 TARO PHARM INDS
LOCOID HYDROCORTISONE BUTYRATE 0.1% CREAM;TOPICAL Prescription Yes AB1 018514 PRECISION DERMAT

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