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Generated: May 26, 2019

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Details for New Drug Application (NDA): 021379

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NDA 021379 describes ELIGARD, which is a drug marketed by Tolmar Therap and is included in four NDAs. It is available from one supplier. There are five 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 021379
Tradename:ELIGARD
Applicant:Tolmar Therap
Ingredient:leuprolide acetate
Patents:4
Formulation / Manufacturing:see details
Medical Subject Heading (MeSH) Categories for 021379
Suppliers and Packaging for NDA: 021379
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ELIGARD leuprolide acetate INJECTABLE;SUBCUTANEOUS 021379 NDA TOLMAR PHARMACEUTICALS INC. 62935-223 62935-223-05 1 KIT in 1 CARTON (62935-223-05) * .375 mL in 1 SYRINGE (62935-224-05) * .375 mL in 1 SYRINGE (62935-221-04)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;SUBCUTANEOUSStrength22.5MG/VIAL
Approval Date:Jul 24, 2002TE:RLD:Yes
Patent:➤ Sign UpPatent Expiration:Mar 27, 2020Product Flag?YSubstance Flag?Delist Request?
Patent:➤ Sign UpPatent Expiration:Oct 15, 2023Product Flag?YSubstance Flag?YDelist Request?
Patented Use:METHOD OF TREATING CANCER
Patent:➤ Sign UpPatent Expiration:Nov 13, 2020Product Flag?YSubstance Flag?Delist Request?

Expired US Patents for NDA 021379

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Tolmar Therap ELIGARD leuprolide acetate INJECTABLE;SUBCUTANEOUS 021379-001 Jul 24, 2002 ➤ Sign Up ➤ Sign Up
Tolmar Therap ELIGARD leuprolide acetate INJECTABLE;SUBCUTANEOUS 021379-001 Jul 24, 2002 ➤ Sign Up ➤ Sign Up
Tolmar Therap ELIGARD leuprolide acetate INJECTABLE;SUBCUTANEOUS 021379-001 Jul 24, 2002 ➤ Sign Up ➤ Sign Up
Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration

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