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Generated: November 19, 2018

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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 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-seven 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:STRIANT
Applicant:Auxilium Pharms Llc
Ingredient:testosterone
Patents:1
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

Profile for product number 001

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

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