Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 080706
Company: CROWN LABS

Products on ANDA 080706

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
ALA-CORT	HYDROCORTISONE	1%	CREAM;TOPICAL	Prescription	AT	No	No
ALA-CORT	HYDROCORTISONE	2.5%	CREAM;TOPICAL	Prescription	AT	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 080706

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
03/09/1973	ORIG-1	Approval				Label is not available on this site.

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
09/22/2015	SUPPL-12	Labeling-Package Insert		Label is not available on this site.
01/28/1997	SUPPL-8	Labeling		Label is not available on this site.
05/22/1992	SUPPL-7	Labeling		Label is not available on this site.
07/10/1985	SUPPL-6	Manufacturing (CMC)		Label is not available on this site.
07/10/1985	SUPPL-5	Manufacturing (CMC)		Label is not available on this site.
05/12/1982	SUPPL-2	Manufacturing (CMC)		Label is not available on this site.

Therapeutic Equivalents for ANDA 080706

ALA-CORT

CREAM;TOPICAL; 1%
TE Code = AT

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
ALA-CORT	HYDROCORTISONE	1%	CREAM;TOPICAL	Prescription	No	AT	080706	CROWN LABS
HYDROCORTISONE	HYDROCORTISONE	1%	CREAM;TOPICAL	Prescription	No	AT	087795	ACTAVIS MID ATLANTIC
HYDROCORTISONE	HYDROCORTISONE	1%	CREAM;TOPICAL	Prescription	Yes	AT	080693	FOUGERA PHARMS INC

CREAM;TOPICAL; 2.5%
TE Code = AT

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
ALA-CORT	HYDROCORTISONE	2.5%	CREAM;TOPICAL	Prescription	No	AT	080706	CROWN LABS
ANUSOL HC	HYDROCORTISONE	2.5%	CREAM;TOPICAL	Prescription	No	AT	088250	SALIX PHARMS
HYDROCORTISONE	HYDROCORTISONE	2.5%	CREAM;TOPICAL	Prescription	No	AT	089682	ACTAVIS MID ATLANTIC
HYDROCORTISONE	HYDROCORTISONE	2.5%	CREAM;TOPICAL	Prescription	No	AT	089414	FOUGERA PHARMS INC
HYDROCORTISONE	HYDROCORTISONE	2.5%	CREAM;TOPICAL	Prescription	No	AT	085025	PADAGIS US
HYDROCORTISONE	HYDROCORTISONE	2.5%	CREAM;TOPICAL	Prescription	No	AT	040879	RISING
HYDROCORTISONE	HYDROCORTISONE	2.5%	CREAM;TOPICAL	Prescription	No	AT	088799	TARO