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Last Updated: November 2, 2024

Details for New Drug Application (NDA): 204570


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NDA 204570 describes TESTOSTERONE, which is a drug marketed by Actavis Labs Ut Inc, Alembic, Amneal, Encube, Lupin, Padagis Israel, Perrigo Israel, Twi Pharms, Xiromed, Ani Pharms, Strides Pharma, Dr Reddys, Watson Labs, Apotex, Cipla, Lupin Ltd, Am Regent, Eugia Pharma, Hikma, Hikma Farmaceutica, Padagis Us, Rising, Sandoz, Sun Pharm Inds Ltd, Watson Pharms Inc, Wilshire Pharms Inc, Azurity, Nexus, Bel Mar, Elkins Sinn, and Lilly, and is included in sixty NDAs. It is available from fourteen suppliers. There are two patents protecting this drug. Additional details are available on the TESTOSTERONE profile page.

The generic ingredient in TESTOSTERONE is testosterone propionate. There are sixty-nine drug master file entries for this compound. Additional details are available on the testosterone propionate profile page.
Summary for 204570
Tradename:TESTOSTERONE
Applicant:Actavis Labs Ut Inc
Ingredient:testosterone
Patents:0
Pharmacology for NDA: 204570
Mechanism of ActionAndrogen Receptor Agonists
Medical Subject Heading (MeSH) Categories for 204570
Suppliers and Packaging for NDA: 204570
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
TESTOSTERONE testosterone GEL, METERED;TRANSDERMAL 204570 ANDA Actavis Pharma, Inc. 0591-2924 0591-2924-18 1 BOTTLE, PUMP in 1 CARTON (0591-2924-18) / 88 g in 1 BOTTLE, PUMP
TESTOSTERONE testosterone GEL, METERED;TRANSDERMAL 204570 ANDA Actavis Pharma, Inc. 0591-2925 0591-2925-30 30 PACKET in 1 CARTON (0591-2925-30) / 1.25 g in 1 PACKET (0591-2925-32)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:GEL, METERED;TRANSDERMALStrength1.62% (20.25MG/1.25GM ACTUATION)
Approval Date:Apr 10, 2019TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:GEL;TRANSDERMALStrength1.62% (20.25MG/1.25GM PACKET)
Approval Date:Jul 17, 2020TE:AB2RLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:GEL;TRANSDERMALStrength1.62% (40.5MG/2.5GM PACKET)
Approval Date:Jul 17, 2020TE:AB2RLD:No

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