Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 202145
Company: GLENMARK PHARMS LTD

Products on ANDA 202145

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

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 202145

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

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
01/08/2024	SUPPL-4	Labeling-Package Insert		Label is not available on this site.

Labels for ANDA 202145

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

Therapeutic Equivalents for ANDA 202145

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