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Details for New Drug Application (NDA): 019762

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NDA 019762 describes TESTODERM, which is a drug marketed by Alza and is included in two NDAs. There are two patents protecting this drug. Additional details are available on the TESTODERM profile page.

The generic ingredient in TESTODERM 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: 019762

Tradename:
TESTODERM
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;TRANSDERMALStrength4MG/24HR
Approval Date:Oct 12, 1993TE:RLD:No
Patent:5,840,327Patent Expiration:Aug 15, 2016Product Flag?Substance Flag?Delist Request?

Summary for product number 002

Active Rx/OTC/Discontinued:DISCNDosage:FILM, EXTENDED RELEASE;TRANSDERMALStrength6MG/24HR
Approval Date:Oct 12, 1993TE:RLD:No
Patent:5,840,327Patent Expiration:Aug 15, 2016Product Flag?Substance Flag?Delist Request?

Expired Orange Book Patents for NDA: 019762

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Alza
TESTODERM
testosterone
FILM, EXTENDED RELEASE;TRANSDERMAL019762-001Oct 12, 19934,704,282► subscribe
Alza
TESTODERM
testosterone
FILM, EXTENDED RELEASE;TRANSDERMAL019762-002Oct 12, 19934,704,282► subscribe
Alza
TESTODERM
testosterone
FILM, EXTENDED RELEASE;TRANSDERMAL019762-002Oct 12, 19934,867,982► subscribe
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