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Generated: November 18, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 021543

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NDA 021543 describes STRIANT, which is a drug marketed by Auxilium Pharms Llc and is included in one NDA. It is available from two suppliers. There is one patent protecting this drug. Additional details are available on the STRIANT profile page.

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

Summary for 021543

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

Pharmacology for NDA: 021543

Ingredient-typeAndrostanes
Mechanism of ActionAndrogen Receptor Agonists

Medical Subject Heading (MeSH) Categories for 021543

Suppliers and Packaging for NDA: 021543

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
STRIANT
testosterone
TABLET, EXTENDED RELEASE;BUCCAL 021543 NDA Endo Pharmaceuticals, Inc. 52244-030 52244-030-60 6 BLISTER PACK in 1 BOX (52244-030-60) > 10 TABLET in 1 BLISTER PACK
STRIANT
testosterone
TABLET, EXTENDED RELEASE;BUCCAL 021543 NDA Columbia Laboratories, Inc. 55056-3060 55056-3060-1 6 BLISTER PACK in 1 CARTON (55056-3060-1) > 10 TABLET in 1 BLISTER PACK

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET, EXTENDED RELEASE;BUCCALStrength30MG
Approval Date:Jun 19, 2003TE:RLD:Yes
Patent:► SubscribePatent Expiration:Aug 23, 2019Product Flag?Substance Flag?Delist Request?
Patented Use:METHOD OF DELIVERING AN ACTIVE INGREDIENT USING A PROGRESSIVE HYDRATION BIOADHESIVE

Expired Orange Book Patents for NDA: 021543

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Auxilium Pharms Llc
STRIANT
testosterone
TABLET, EXTENDED RELEASE;BUCCAL021543-001Jun 19, 2003► Subscribe► Subscribe
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Serving leading biopharmaceutical companies globally:

Harvard Business School
Queensland Health
McKesson
Julphar
Chinese Patent Office
Accenture
Merck
Fuji
Daiichi Sankyo
AstraZeneca

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