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Generated: December 14, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 021343

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NDA 021343 describes ELIGARD, which is a drug marketed by Tolmar Therap and is included in four NDAs. It is available from one supplier. There are ten patents protecting this drug. Additional details are available on the ELIGARD profile page.

The generic ingredient in ELIGARD is leuprolide acetate. There are twenty-two drug master file entries for this compound. Five suppliers are listed for this compound. Additional details are available on the leuprolide acetate profile page.
Summary for 021343
Tradename:ELIGARD
Applicant:Tolmar Therap
Ingredient:leuprolide acetate
Patents:4
Formulation / Manufacturing:see details
Medical Subject Heading (MeSH) Categories for 021343
Suppliers and Packaging for NDA: 021343
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ELIGARD leuprolide acetate INJECTABLE;SUBCUTANEOUS 021343 NDA TOLMAR PHARMACEUTICALS INC. 62935-752 62935-752-75 1 KIT in 1 CARTON (62935-752-75) * .25 mL in 1 SYRINGE (62935-751-74) * .25 mL in 1 SYRINGE (62935-750-75)
ELIGARD leuprolide acetate INJECTABLE;SUBCUTANEOUS 021343 NDA TOLMAR PHARMACEUTICALS INC. 62935-753 62935-753-75 1 KIT in 1 CARTON (62935-753-75) * .25 mL in 1 SYRINGE (62935-754-74) * .25 mL in 1 SYRINGE (62935-755-75)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;SUBCUTANEOUSStrength7.5MG/VIAL
Approval Date:Jan 23, 2002TE:RLD:Yes
Patent:➤ Sign UpPatent Expiration:Oct 28, 2018Product Flag?YSubstance Flag?Delist Request?
Patented Use:METHOD OF TREATING CANCER
Patent:➤ Sign UpPatent Expiration:Mar 27, 2020Product Flag?YSubstance Flag?Delist Request?
Patent:➤ Sign UpPatent Expiration:Oct 28, 2018Product Flag?YSubstance Flag?Delist Request?
Patented Use:METHOD OF TREATING CANCER

Expired US Patents for NDA 021343

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Tolmar Therap ELIGARD leuprolide acetate INJECTABLE;SUBCUTANEOUS 021343-001 Jan 23, 2002 ➤ Sign Up ➤ Sign Up
Tolmar Therap ELIGARD leuprolide acetate INJECTABLE;SUBCUTANEOUS 021343-001 Jan 23, 2002 ➤ Sign Up ➤ Sign Up
Tolmar Therap ELIGARD leuprolide acetate INJECTABLE;SUBCUTANEOUS 021343-001 Jan 23, 2002 ➤ Sign Up ➤ Sign Up
Tolmar Therap ELIGARD leuprolide acetate INJECTABLE;SUBCUTANEOUS 021343-001 Jan 23, 2002 ➤ Sign Up ➤ Sign Up
Tolmar Therap ELIGARD leuprolide acetate INJECTABLE;SUBCUTANEOUS 021343-001 Jan 23, 2002 ➤ Sign Up ➤ Sign Up
Tolmar Therap ELIGARD leuprolide acetate INJECTABLE;SUBCUTANEOUS 021343-001 Jan 23, 2002 ➤ Sign Up ➤ Sign Up
Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration

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