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Details for New Drug Application (NDA): 021543

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NDA 021543 describes STRIANT, which is a drug marketed by Auxilium Pharms Inc 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-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: 021543

Tradename:
STRIANT
Applicant:
Auxilium Pharms Inc
Ingredient:
testosterone
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

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:6,248,358Patent 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 Inc
STRIANT
testosterone
TABLET, EXTENDED RELEASE;BUCCAL021543-001Jun 19, 20034,615,697► subscribe
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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.

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