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Details for New Drug Application (NDA): 020791

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NDA 020791 describes TESTODERM TTS, which is a drug marketed by Alza and is included in one NDA. There is one patent protecting this drug. Additional details are available on the TESTODERM TTS profile page.

The generic ingredient in TESTODERM TTS is testosterone. There are sixty-one drug master file entries for this compound. Nineteen suppliers are listed for this compound. There are two tentative approvals for this compound. Additional details are available on the testosterone profile page.

Summary for NDA: 020791

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

Summary for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:FILM, EXTENDED RELEASE;TRANSDERMALStrength5MG/24HR
Approval Date:Dec 18, 1997TE:RLD:No
Patent:6,348,210Patent Expiration:Nov 10, 2019Product Flag?Substance Flag?Delist Request?
Patented Use:METHOD FOR TRANSDERMAL ADMINISTRATION OF A DRUG THROUGH NON-SCROTAL SKIN USING A TRANSDERMAL DRUG DELIVERY DEVICE CONTAINING THE DRUG AND HAVING AN ADHESIVE SURFACE

Expired Orange Book Patents for NDA: 020791

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Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Alza
TESTODERM TTS
testosterone
FILM, EXTENDED RELEASE;TRANSDERMAL020791-001Dec 18, 19974,379,454► subscribe
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