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Last Updated: March 19, 2024

Details for New Drug Application (NDA): 076737


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NDA 076737 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, Dash Pharms, Lupin Ltd, Am Regent, Eugia Pharma, Hikma, Hikma Farmaceutica, Padagis Us, Rising, Sandoz, Sun Pharm Inds Ltd, Watson Pharms Inc, Wilshire Pharms Inc, Slayback Pharma Llc, Nexus, Bel Mar, Elkins Sinn, and Lilly, and is included in fifty-nine NDAs. It is available from fifteen 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 076737
Tradename:TESTOSTERONE
Applicant:Actavis Labs Ut Inc
Ingredient:testosterone
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 076737
Mechanism of ActionAndrogen Receptor Agonists
Medical Subject Heading (MeSH) Categories for 076737
Suppliers and Packaging for NDA: 076737
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
TESTOSTERONE testosterone GEL, METERED;TRANSDERMAL 076737 ANDA Actavis Pharma, Inc. 0591-2921 0591-2921-02 2 BOTTLE, PUMP in 1 CARTON (0591-2921-02) / 75 g in 1 BOTTLE, PUMP (0591-2921-18)
TESTOSTERONE testosterone GEL, METERED;TRANSDERMAL 076737 ANDA Actavis Pharma, Inc. 0591-3216 0591-3216-30 30 PACKET in 1 CARTON (0591-3216-30) / 2.5 g in 1 PACKET (0591-3216-17)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:GEL;TRANSDERMALStrength25MG/2.5GM PACKET
Approval Date:Jan 27, 2006TE:AB1RLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:GEL;TRANSDERMALStrength50MG/5GM PACKET
Approval Date:Jan 27, 2006TE:AB1RLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:GEL, METERED;TRANSDERMALStrength12.5MG/1.25GM ACTUATION
Approval Date:Mar 9, 2015TE:BXRLD:No

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