Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 091073
Company: ACTAVIS LABS UT INC

Products on ANDA 091073

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
TESTOSTERONE	TESTOSTERONE	50MG/5GM PACKET	GEL;TRANSDERMAL	Prescription	AB2	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 091073

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
09/18/2017	ORIG-1	Approval	Not Applicable		Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/091073Orig1s000ltr.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
02/07/2024	SUPPL-6	Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.
02/07/2024	SUPPL-3	Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.
06/21/2019	SUPPL-2	Labeling-Package Insert, Labeling-Medication Guide		Label is not available on this site.

Therapeutic Equivalents for ANDA 091073

TESTOSTERONE

GEL;TRANSDERMAL; 50MG/5GM PACKET
TE Code = AB2

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
TESTIM	TESTOSTERONE	50MG/5GM PACKET	GEL;TRANSDERMAL	Prescription	Yes	AB2	021454	AUXILIUM PHARMS LLC
TESTOSTERONE	TESTOSTERONE	50MG/5GM PACKET	GEL;TRANSDERMAL	Prescription	No	AB2	091073	ACTAVIS LABS UT INC
VOGELXO	TESTOSTERONE	50MG/5GM PACKET	GEL;TRANSDERMAL	Prescription	No	AB2	204399	UPSHER SMITH LABS