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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 four patents protecting this drug. Additional details are available on the ELIGARD profile page.

The generic ingredient in ELIGARD is leuprolide acetate. There are twenty drug master file entries for this compound. Eight suppliers are listed for this compound. Additional details are available on the leuprolide acetate profile page.

Summary for NDA: 021379

Tradename:
ELIGARD
Applicant:
Tolmar Therap
Ingredient:
leuprolide acetate
Patents:4
Therapeutic Class:Hormonal Agents, Suppressant (Pituitary)
Formulation / Manufacturing:see details

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. 62935-222 62935-222-05 1 KIT in 1 CARTON (62935-222-05) * .375 mL in 1 SYRINGE (62935-220-04) * .375 mL in 1 SYRINGE (62935-225-05)
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 (62935-221-04) * .375 mL in 1 SYRINGE (62935-224-05)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;SUBCUTANEOUSStrength22.5MG/VIAL
Approval Date:Jul 24, 2002TE:RLD:Yes
Patent:6,626,870Patent Expiration:Mar 27, 2020Product Flag?YSubstance Flag?Delist Request?
Patent:9,283,282Patent Expiration:Oct 28, 2018Product Flag?YSubstance Flag?YDelist Request?
Patent:6,565,874Patent Expiration:Oct 28, 2018Product Flag?YSubstance Flag?Delist Request?
Patented Use:METHOD OF TREATING CANCER

Expired Orange Book Patents for NDA: 021379

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Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Tolmar Therap
ELIGARD
leuprolide acetate
INJECTABLE;SUBCUTANEOUS021379-001Jul 24, 20024,938,763► subscribe
Tolmar Therap
ELIGARD
leuprolide acetate
INJECTABLE;SUBCUTANEOUS021379-001Jul 24, 20025,733,950► subscribe
Tolmar Therap
ELIGARD
leuprolide acetate
INJECTABLE;SUBCUTANEOUS021379-001Jul 24, 20026,395,293► subscribe
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