Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 205134
Company: ACTAVIS MID ATLANTIC

Products on ANDA 205134

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 205134

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
12/08/2017	ORIG-1	Approval		STANDARD		Label is not available on this site.

Therapeutic Equivalents for ANDA 205134

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