Details for New Drug Application (NDA): 021731
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NDA 021731 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 are twenty-two drug master file entries 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 are twenty-two drug master file entries for this compound. Seventeen suppliers are listed for this compound. Additional details are available on the leuprolide acetate profile page.
Summary for 021731
| Tradename: | ELIGARD KIT |
| Applicant: | Tolmar |
| Ingredient: | leuprolide acetate |
| Patents: | 3 |
Pharmacology for NDA: 021731
| Mechanism of Action | Gonadotropin Releasing Hormone Receptor Agonists |
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 KIT | leuprolide acetate | POWDER;SUBCUTANEOUS | 021731 | NDA | TOLMAR Inc. | 62935-453 | 62935-453-45 | 1 KIT in 1 CARTON (62935-453-45) * .375 mL in 1 SYRINGE (62935-454-44) * .375 mL in 1 SYRINGE (62935-455-45) |
| ELIGARD KIT | leuprolide acetate | POWDER;SUBCUTANEOUS | 021731 | NDA | TOLMAR Inc. | 62935-461 | 62935-461-50 | 1 SYRINGE in 1 CARTON (62935-461-50) / .375 mL in 1 SYRINGE |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | POWDER;SUBCUTANEOUS | Strength | 45MG | ||||
| Approval Date: | Dec 14, 2004 | 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 021731
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Tolmar | ELIGARD KIT | leuprolide acetate | POWDER;SUBCUTANEOUS | 021731-001 | Dec 14, 2004 | ⤷ Start Trial | ⤷ Start Trial |
| Tolmar | ELIGARD KIT | leuprolide acetate | POWDER;SUBCUTANEOUS | 021731-001 | Dec 14, 2004 | ⤷ Start Trial | ⤷ Start Trial |
| Tolmar | ELIGARD KIT | leuprolide acetate | POWDER;SUBCUTANEOUS | 021731-001 | Dec 14, 2004 | ⤷ Start Trial | ⤷ Start Trial |
| Tolmar | ELIGARD KIT | leuprolide acetate | POWDER;SUBCUTANEOUS | 021731-001 | Dec 14, 2004 | ⤷ Start Trial | ⤷ Start Trial |
| Tolmar | ELIGARD KIT | leuprolide acetate | POWDER;SUBCUTANEOUS | 021731-001 | Dec 14, 2004 | ⤷ Start Trial | ⤷ Start Trial |
| Tolmar | ELIGARD KIT | leuprolide acetate | POWDER;SUBCUTANEOUS | 021731-001 | Dec 14, 2004 | ⤷ Start Trial | ⤷ Start Trial |
| Tolmar | ELIGARD KIT | leuprolide acetate | POWDER;SUBCUTANEOUS | 021731-001 | Dec 14, 2004 | ⤷ Start Trial | ⤷ Start Trial |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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