Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 076744
Company: STRIDES PHARMA INTL

Products on ANDA 076744

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

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 076744

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
05/23/2007	ORIG-1	Approval			Review (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/anda/2007/076744Orig1s000.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
07/16/2024	SUPPL-18	Labeling-Patient Package Insert, Labeling-Medication Guide, Labeling-Container/Carton Labels		Label is not available on this site.
06/03/2019	SUPPL-10	Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.
06/03/2019	SUPPL-9	Labeling-Package Insert		Label is not available on this site.
06/03/2019	SUPPL-8	Labeling-Container/Carton Labels, Labeling-Package Insert		Label is not available on this site.
06/30/2015	SUPPL-6	Labeling-Package Insert		Label is not available on this site.
09/25/2015	SUPPL-5	REMS-Proposal		Label is not available on this site.
06/30/2015	SUPPL-4	Labeling-Package Insert		Label is not available on this site.
06/30/2015	SUPPL-3	Labeling-Package Insert		Label is not available on this site.
01/06/2009	SUPPL-1	Labeling		Label is not available on this site.

Therapeutic Equivalents for ANDA 076744

TESTOSTERONE

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

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