Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 204571
Company: ACTAVIS LABS UT INC

• REMS

Products on ANDA 204571

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
TESTOSTERONE	TESTOSTERONE	10MG/0.5GM ACTUATION	GEL, METERED;TRANSDERMAL	Prescription	AB	No	Yes

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 204571

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
08/05/2015	ORIG-1	Approval			Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/204571Orig1s000ltr.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
06/21/2019	SUPPL-5	Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.
06/21/2019	SUPPL-3	Labeling-Package Insert		Label is not available on this site.

Therapeutic Equivalents for ANDA 204571

TESTOSTERONE

GEL, METERED;TRANSDERMAL; 10MG/0.5GM ACTUATION
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
TESTOSTERONE	TESTOSTERONE	10MG/0.5GM ACTUATION	GEL, METERED;TRANSDERMAL	Prescription	No	AB	204571	ACTAVIS LABS UT INC