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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 020769
Company: PRECISION DERMAT

Products on NDA 020769

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

Approval Date(s) and History, Letters, Labels, Reviews for NDA 020769

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-Container/Carton Labels, Labeling-Package Insert	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.

Labels for NDA 020769

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

Therapeutic Equivalents for NDA 020769

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 PHARMS LTD
LOCOID LIPOCREAM	HYDROCORTISONE BUTYRATE	0.1%	CREAM;TOPICAL	Prescription	Yes	AB2	020769	PRECISION DERMAT

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