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Serving leading biopharmaceutical companies globally:

Cerilliant
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Generated: November 22, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 076737

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NDA 076737 describes TESTOSTERONE, which is a drug marketed by Watson Labs, Actavis Labs Ut Inc, Par Pharm, Perrigo Israel, Ani Pharms Inc, Perrigo Uk Finco, Sandoz Inc, Sun Pharm Inds Ltd, Paddock Llc, Watson Pharms Inc, Luitpold Pharms Inc, Hikma Farmaceutica, Mylan Institutional, West-ward Pharms Int, Bel Mar, Lilly, and Elkins Sinn, and is included in forty NDAs. It is available from three suppliers. Additional details are available on the TESTOSTERONE profile page.

The generic ingredient in TESTOSTERONE is testosterone propionate. There are sixty-two drug master file entries for this compound. Additional details are available on the testosterone propionate profile page.

Summary for 076737

Tradename:
1
Applicant:
1
Ingredient:
1
Patents:0
Therapeutic Class:Hormonal Agents, Stimulant/Replacement/Modifying (Sex Hormones/Modifiers)
Formulation / Manufacturing:see details

Pharmacology for NDA: 076737

Ingredient-typeAndrostanes
Mechanism of ActionAndrogen Receptor Agonists

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)

Summary for product number 001

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

Summary for product number 002

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

Summary for product number 003

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


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Serving leading biopharmaceutical companies globally:

Julphar
Baxter
Healthtrust
Cerilliant
Federal Trade Commission
Argus Health
Colorcon
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McKesson
Novartis

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