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Last Updated: March 26, 2023

Details for New Drug Application (NDA): 021379


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NDA 021379 describes ELIGARD KIT, which is a drug marketed by Tolmar Therap and is included in four NDAs. It is available from two suppliers. There is one patent protecting this drug. Additional details are available on the ELIGARD KIT profile page.

The generic ingredient in ELIGARD KIT is leuprolide acetate. There are twenty-two drug master file entries for this compound. Eleven suppliers are listed for this compound. Additional details are available on the leuprolide acetate profile page.
Summary for 021379
Tradename:ELIGARD KIT
Applicant:Tolmar Therap
Ingredient:leuprolide acetate
Patents:1
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 KIT leuprolide acetate POWDER;SUBCUTANEOUS 021379 NDA TOLMAR PHARMACEUTICALS INC. 62935-223 62935-223-05 1 KIT in 1 CARTON (62935-223-05) * .375 mL in 1 SYRINGE (62935-221-04) * .375 mL in 1 SYRINGE (62935-224-05)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:POWDER;SUBCUTANEOUSStrength22.5MG
Approval Date:Jul 24, 2002TE:RLD:Yes
Patent:See Plans and PricingPatent Expiration:Oct 15, 2023Product Flag?YSubstance Flag?YDelist Request?
Patented Use:METHOD OF TREATING CANCER

Expired US Patents for NDA 021379

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Tolmar Therap ELIGARD KIT leuprolide acetate POWDER;SUBCUTANEOUS 021379-001 Jul 24, 2002 See Plans and Pricing See Plans and Pricing
Tolmar Therap ELIGARD KIT leuprolide acetate POWDER;SUBCUTANEOUS 021379-001 Jul 24, 2002 See Plans and Pricing See Plans and Pricing
Tolmar Therap ELIGARD KIT leuprolide acetate POWDER;SUBCUTANEOUS 021379-001 Jul 24, 2002 See Plans and Pricing See Plans and Pricing
Tolmar Therap ELIGARD KIT leuprolide acetate POWDER;SUBCUTANEOUS 021379-001 Jul 24, 2002 See Plans and Pricing See Plans and Pricing
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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