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Generated: November 13, 2018

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Details for New Drug Application (NDA): 021732

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NDA 021732 describes VANTAS, which is a drug marketed by Endo Pharm and is included in one NDA. It is available from one supplier. Additional details are available on the VANTAS profile page.

The generic ingredient in VANTAS is histrelin acetate. There are two drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the histrelin acetate profile page.
Summary for 021732
Tradename:VANTAS
Applicant:Endo Pharm
Ingredient:histrelin acetate
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 021732
Suppliers and Packaging for NDA: 021732
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
VANTAS histrelin acetate IMPLANT;SUBCUTANEOUS 021732 NDA Endo Pharmaceuticals Solutions Inc. 67979-500 67979-500-01 1 VIAL, GLASS in 1 CARTON (67979-500-01) > 1 IMPLANT in 1 VIAL, GLASS

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:IMPLANT;SUBCUTANEOUSStrength50MG
Approval Date:Oct 12, 2004TE:RLD:Yes

Expired US Patents for NDA 021732

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Endo Pharm VANTAS histrelin acetate IMPLANT;SUBCUTANEOUS 021732-001 Oct 12, 2004 ➤ Try a Free Trial ➤ Try a Free Trial
Endo Pharm VANTAS histrelin acetate IMPLANT;SUBCUTANEOUS 021732-001 Oct 12, 2004 ➤ Try a Free Trial ➤ Try a Free Trial
Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration

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