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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 212984
Company: ENCUBE

Products on ANDA 212984

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
TESTOSTERONE	TESTOSTERONE	50MG/5GM PACKET	GEL;TRANSDERMAL	Prescription	AB1	No	No
TESTOSTERONE	TESTOSTERONE	12.5MG/1.25GM ACTUATION	GEL, METERED;TRANSDERMAL	Prescription	AB1	No	No
TESTOSTERONE	TESTOSTERONE	25MG/2.5GM PACKET	GEL;TRANSDERMAL	Prescription	AB1	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 212984

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
11/09/2021	ORIG-1	Approval		STANDARD		Label is not available on this site.

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
12/17/2025	SUPPL-10	Labeling-Package Insert, Labeling-Patient Package Insert		Label is not available on this site.

Therapeutic Equivalents for ANDA 212984

TESTOSTERONE

GEL;TRANSDERMAL; 50MG/5GM PACKET
TE Code = AB1

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
ANDROGEL	TESTOSTERONE	50MG/5GM PACKET	GEL;TRANSDERMAL	Prescription	Yes	AB1	021015	BESINS HLTHCARE
TESTOSTERONE	TESTOSTERONE	50MG/5GM PACKET	GEL;TRANSDERMAL	Prescription	No	AB1	076737	ACTAVIS LABS UT INC
TESTOSTERONE	TESTOSTERONE	50MG/5GM PACKET	GEL;TRANSDERMAL	Prescription	No	AB1	212984	ENCUBE
TESTOSTERONE	TESTOSTERONE	50MG/5GM PACKET	GEL;TRANSDERMAL	Prescription	No	AB1	076744	STRIDES PHARMA INTL

GEL, METERED;TRANSDERMAL; 12.5MG/1.25GM ACTUATION
TE Code = AB1

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
ANDROGEL	TESTOSTERONE	12.5MG/1.25GM ACTUATION	GEL, METERED;TRANSDERMAL	Prescription	Yes	AB1	021015	BESINS HLTHCARE
TESTOSTERONE	TESTOSTERONE	12.5MG/1.25GM ACTUATION	GEL, METERED;TRANSDERMAL	Prescription	No	AB1	076737	ACTAVIS LABS UT INC
TESTOSTERONE	TESTOSTERONE	12.5MG/1.25GM ACTUATION	GEL, METERED;TRANSDERMAL	Prescription	No	AB1	212984	ENCUBE

GEL;TRANSDERMAL; 25MG/2.5GM PACKET
TE Code = AB1

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
ANDROGEL	TESTOSTERONE	25MG/2.5GM PACKET	GEL;TRANSDERMAL	Prescription	Yes	AB1	021015	BESINS HLTHCARE
TESTOSTERONE	TESTOSTERONE	25MG/2.5GM PACKET	GEL;TRANSDERMAL	Prescription	No	AB1	076737	ACTAVIS LABS UT INC
TESTOSTERONE	TESTOSTERONE	25MG/2.5GM PACKET	GEL;TRANSDERMAL	Prescription	No	AB1	212984	ENCUBE
TESTOSTERONE	TESTOSTERONE	25MG/2.5GM PACKET	GEL;TRANSDERMAL	Prescription	No	AB1	076744	STRIDES PHARMA INTL

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