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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. Eighteen 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

Auxilium Pharms Inc
Therapeutic Class:Hormonal Agents, Stimulant/Replacement/Modifying (Sex Hormones/Modifiers)
Formulation / Manufacturing:see details

Pharmacology for NDA: 021543

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
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
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?

Expired Orange Book Patents for NDA: 021543

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Auxilium Pharms Inc
TABLET, EXTENDED RELEASE;BUCCAL021543-001Jun 19, 20034,615,697► subscribe
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