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Generated: November 13, 2018

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Details for New Drug Application (NDA): 021731

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NDA 021731 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 021731
Tradename:ELIGARD
Applicant:Tolmar Therap
Ingredient:leuprolide acetate
Patents:9
Formulation / Manufacturing:see details
Medical Subject Heading (MeSH) Categories for 021731
Suppliers and Packaging for NDA: 021731
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ELIGARD leuprolide acetate INJECTABLE;SUBCUTANEOUS 021731 NDA TOLMAR PHARMACEUTICALS INC. 62935-452 62935-452-45 1 KIT in 1 CARTON (62935-452-45) * .375 mL in 1 SYRINGE (62935-450-45) * .375 mL in 1 SYRINGE (62935-451-44)
ELIGARD leuprolide acetate INJECTABLE;SUBCUTANEOUS 021731 NDA TOLMAR PHARMACEUTICALS INC. 62935-453 62935-453-45 1 KIT in 1 CARTON (62935-453-45) * .375 mL in 1 SYRINGE (62935-455-45) * .375 mL in 1 SYRINGE (62935-454-44)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;SUBCUTANEOUSStrength45MG/VIAL
Approval Date:Dec 14, 2004TE:RLD:Yes
Patent:➤ Try a Free TrialPatent Expiration:Oct 28, 2018Product Flag?YSubstance Flag?Delist Request?
Patented Use:METHOD OF TREATING CANCER
Patent:➤ Try a Free TrialPatent Expiration:Mar 27, 2020Product Flag?YSubstance Flag?Delist Request?
Patent:➤ Try a Free TrialPatent Expiration:Oct 28, 2018Product Flag?Substance Flag?Delist Request?
Patented Use:METHOD OF TREATING CANCER

Expired US Patents for NDA 021731

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Tolmar Therap ELIGARD leuprolide acetate INJECTABLE;SUBCUTANEOUS 021731-001 Dec 14, 2004 ➤ Try a Free Trial ➤ Try a Free Trial
Tolmar Therap ELIGARD leuprolide acetate INJECTABLE;SUBCUTANEOUS 021731-001 Dec 14, 2004 ➤ Try a Free Trial ➤ Try a Free Trial
Tolmar Therap ELIGARD leuprolide acetate INJECTABLE;SUBCUTANEOUS 021731-001 Dec 14, 2004 ➤ Try a Free Trial ➤ Try a Free Trial
Tolmar Therap ELIGARD leuprolide acetate INJECTABLE;SUBCUTANEOUS 021731-001 Dec 14, 2004 ➤ Try a Free Trial ➤ Try a Free Trial
Tolmar Therap ELIGARD leuprolide acetate INJECTABLE;SUBCUTANEOUS 021731-001 Dec 14, 2004 ➤ Try a Free Trial ➤ Try a Free Trial
Tolmar Therap ELIGARD leuprolide acetate INJECTABLE;SUBCUTANEOUS 021731-001 Dec 14, 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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