Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 076977
Company: ENCUBE

Products on ANDA 076977

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
CLOBETASOL PROPIONATE	CLOBETASOL PROPIONATE	0.05%	SOLUTION;TOPICAL	Prescription	AT	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 076977

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
08/05/2005	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
09/06/2019	SUPPL-11	Labeling-Package Insert		Label is not available on this site.

Therapeutic Equivalents for ANDA 076977

CLOBETASOL PROPIONATE

SOLUTION;TOPICAL; 0.05%
TE Code = AT

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
CLOBETASOL PROPIONATE	CLOBETASOL PROPIONATE	0.05%	SOLUTION;TOPICAL	Prescription	No	AT	212881	ALEMBIC
CLOBETASOL PROPIONATE	CLOBETASOL PROPIONATE	0.05%	SOLUTION;TOPICAL	Prescription	No	AT	076977	ENCUBE
CLOBETASOL PROPIONATE	CLOBETASOL PROPIONATE	0.05%	SOLUTION;TOPICAL	Prescription	No	AT	075391	FOUGERA PHARMS
CLOBETASOL PROPIONATE	CLOBETASOL PROPIONATE	0.05%	SOLUTION;TOPICAL	Prescription	No	AT	209361	MACLEODS PHARMS LTD
CLOBETASOL PROPIONATE	CLOBETASOL PROPIONATE	0.05%	SOLUTION;TOPICAL	Prescription	No	AT	206075	NOVEL LABS INC
CLOBETASOL PROPIONATE	CLOBETASOL PROPIONATE	0.05%	SOLUTION;TOPICAL	Prescription	No	AT	211240	QUAGEN
CLOBETASOL PROPIONATE	CLOBETASOL PROPIONATE	0.05%	SOLUTION;TOPICAL	Prescription	No	AT	211494	SAPTALIS PHARMS
CLOBETASOL PROPIONATE	CLOBETASOL PROPIONATE	0.05%	SOLUTION;TOPICAL	Prescription	No	AT	075224	SUN PHARMA CANADA