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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 204255
Company: PADAGIS ISRAEL

REMS

Products on ANDA 204255

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	Yes

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 204255

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
02/28/2017	ORIG-1	Approval			Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/204255Orig1s000lbl.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
05/31/2019	SUPPL-5	REMS - MODIFIED - D-N-A		Label is not available on this site.
05/10/2019	SUPPL-4	Labeling-Package Insert, Labeling-Medication Guide		Label is not available on this site.
04/24/2019	SUPPL-3	Labeling-Container/Carton Labels		Label is not available on this site.
04/24/2019	SUPPL-2	Labeling-Container/Carton Labels		Label is not available on this site.

Labels for ANDA 204255

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
02/28/2017	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/204255Orig1s000lbl.pdf

Therapeutic Equivalents for ANDA 204255

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	ENCUBE
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

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