Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 205328
Company: ACTAVIS LABS UT INC

Products on ANDA 205328

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
TESTOSTERONE	TESTOSTERONE	30MG/1.5ML ACTUATION	SOLUTION, METERED;TRANSDERMAL	Prescription	AT	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 205328

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
08/07/2017	ORIG-1	Approval		STANDARD	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/205328Orig1s000ltr.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
06/11/2019	SUPPL-2	REMS - MODIFIED - D-N-A		Label is not available on this site.
05/10/2019	SUPPL-1	Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.

Therapeutic Equivalents for ANDA 205328

TESTOSTERONE

SOLUTION, METERED;TRANSDERMAL; 30MG/1.5ML ACTUATION
TE Code = AT

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
TESTOSTERONE	TESTOSTERONE	30MG/1.5ML ACTUATION	SOLUTION, METERED;TRANSDERMAL	Prescription	No	AT	205328	ACTAVIS LABS UT INC
TESTOSTERONE	TESTOSTERONE	30MG/1.5ML ACTUATION	SOLUTION, METERED;TRANSDERMAL	Prescription	No	AT	209533	CIPLA
TESTOSTERONE	TESTOSTERONE	30MG/1.5ML ACTUATION	SOLUTION, METERED;TRANSDERMAL	Prescription	No	AT	212301	FEMPHARM
TESTOSTERONE	TESTOSTERONE	30MG/1.5ML ACTUATION	SOLUTION, METERED;TRANSDERMAL	Prescription	No	AT	208061	LUPIN LTD
TESTOSTERONE	TESTOSTERONE	30MG/1.5ML ACTUATION	SOLUTION, METERED;TRANSDERMAL	Prescription	No	AT	204255	PADAGIS ISRAEL
TESTOSTERONE	TESTOSTERONE	30MG/1.5ML ACTUATION	SOLUTION, METERED;TRANSDERMAL	Prescription	No	AT	209836	TWI PHARMS