Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

Abbreviated New Drug Application (ANDA): 208061
Company: LUPIN

Products on ANDA 208061

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 208061

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
10/23/2017	ORIG-1	Approval		STANDARD	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/208061Orig1s000ltr.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
07/11/2025	SUPPL-13	Labeling-Package Insert, Labeling-Medication Guide		Label is not available on this site.
01/29/2020	SUPPL-4	Labeling-Container/Carton Labels		Label is not available on this site.
06/04/2019	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 208061

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	208061	LUPIN
TESTOSTERONE	TESTOSTERONE	30MG/1.5ML ACTUATION	SOLUTION, METERED;TRANSDERMAL	Prescription	No	AT	204255	PADAGIS ISRAEL