Details for New Drug Application (NDA): 021379
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NDA 021379 describes ELIGARD KIT, which is a drug marketed by Tolmar and is included in four NDAs. It is available from two suppliers. There are three patents protecting this drug. Additional details are available on the ELIGARD KIT profile page.
The generic ingredient in ELIGARD KIT is leuprolide acetate. There is one drug master file entry for this compound. Seventeen suppliers are listed for this compound. Additional details are available on the leuprolide acetate profile page.
The generic ingredient in ELIGARD KIT is leuprolide acetate. There is one drug master file entry for this compound. Seventeen suppliers are listed for this compound. Additional details are available on the leuprolide acetate profile page.
Summary for 021379
| Tradename: | ELIGARD KIT |
| Applicant: | Tolmar |
| Ingredient: | leuprolide acetate |
| Patents: | 3 |
Pharmacology for NDA: 021379
| Mechanism of Action | Gonadotropin Releasing Hormone Receptor Agonists |
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 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) |
| ELIGARD KIT | leuprolide acetate | POWDER;SUBCUTANEOUS | 021379 | NDA | TOLMAR Inc. | 62935-227 | 62935-227-10 | 1 SYRINGE in 1 CARTON (62935-227-10) / .375 mL in 1 SYRINGE |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | POWDER;SUBCUTANEOUS | Strength | 22.5MG | ||||
| Approval Date: | Jul 24, 2002 | TE: | RLD: | Yes | |||||
| Patent: | ⤷ Start Trial | Patent Expiration: | Dec 22, 2041 | Product Flag? | Y | Substance Flag? | Y | Delist Request? | |
| Patent: | ⤷ Start Trial | Patent Expiration: | Dec 22, 2041 | Product Flag? | Substance Flag? | Y | Delist Request? | ||
| Patent: | ⤷ Start Trial | Patent Expiration: | Dec 22, 2041 | Product Flag? | Substance Flag? | Delist Request? | |||
| Patented Use: | TREATMENT OF ADVANCED PROSTATIC CANCER | ||||||||
Expired US Patents for NDA 021379
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Tolmar | ELIGARD KIT | leuprolide acetate | POWDER;SUBCUTANEOUS | 021379-001 | Jul 24, 2002 | ⤷ Start Trial | ⤷ Start Trial |
| Tolmar | ELIGARD KIT | leuprolide acetate | POWDER;SUBCUTANEOUS | 021379-001 | Jul 24, 2002 | ⤷ Start Trial | ⤷ Start Trial |
| Tolmar | ELIGARD KIT | leuprolide acetate | POWDER;SUBCUTANEOUS | 021379-001 | Jul 24, 2002 | ⤷ Start Trial | ⤷ Start Trial |
| Tolmar | ELIGARD KIT | leuprolide acetate | POWDER;SUBCUTANEOUS | 021379-001 | Jul 24, 2002 | ⤷ Start Trial | ⤷ Start Trial |
| Tolmar | ELIGARD KIT | leuprolide acetate | POWDER;SUBCUTANEOUS | 021379-001 | Jul 24, 2002 | ⤷ Start Trial | ⤷ Start Trial |
| Tolmar | ELIGARD KIT | leuprolide acetate | POWDER;SUBCUTANEOUS | 021379-001 | Jul 24, 2002 | ⤷ Start Trial | ⤷ Start Trial |
| Tolmar | ELIGARD KIT | leuprolide acetate | POWDER;SUBCUTANEOUS | 021379-001 | Jul 24, 2002 | ⤷ Start Trial | ⤷ Start Trial |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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