Details for New Drug Application (NDA): 021488
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NDA 021488 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. Fifteen 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. Fifteen suppliers are listed for this compound. Additional details are available on the leuprolide acetate profile page.
Summary for 021488
| Tradename: | ELIGARD KIT |
| Applicant: | Tolmar |
| Ingredient: | leuprolide acetate |
| Patents: | 3 |
Pharmacology for NDA: 021488
| Mechanism of Action | Gonadotropin Releasing Hormone Receptor Agonists |
Medical Subject Heading (MeSH) Categories for 021488
Suppliers and Packaging for NDA: 021488
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| ELIGARD KIT | leuprolide acetate | POWDER;SUBCUTANEOUS | 021488 | NDA | TOLMAR Inc. | 62935-303 | 62935-303-30 | 1 KIT in 1 CARTON (62935-303-30) * .5 mL in 1 SYRINGE (62935-305-29) * .5 mL in 1 SYRINGE (62935-304-30) |
| ELIGARD KIT | leuprolide acetate | POWDER;SUBCUTANEOUS | 021488 | NDA | TOLMAR Inc. | 62935-306 | 62935-306-40 | 1 SYRINGE in 1 CARTON (62935-306-40) / .5 mL in 1 SYRINGE |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | POWDER;SUBCUTANEOUS | Strength | 30MG | ||||
| Approval Date: | Feb 13, 2003 | TE: | RLD: | Yes | |||||
| Patent: | ⤷ Get Started Free | Patent Expiration: | Dec 22, 2041 | Product Flag? | Y | Substance Flag? | Y | Delist Request? | |
| Patent: | ⤷ Get Started Free | Patent Expiration: | Dec 22, 2041 | Product Flag? | Substance Flag? | Y | Delist Request? | ||
| Patent: | ⤷ Get Started Free | Patent Expiration: | Dec 22, 2041 | Product Flag? | Substance Flag? | Delist Request? | |||
| Patented Use: | TREATMENT OF ADVANCED PROSTATIC CANCER | ||||||||
Expired US Patents for NDA 021488
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Tolmar | ELIGARD KIT | leuprolide acetate | POWDER;SUBCUTANEOUS | 021488-001 | Feb 13, 2003 | ⤷ Get Started Free | ⤷ Get Started Free |
| Tolmar | ELIGARD KIT | leuprolide acetate | POWDER;SUBCUTANEOUS | 021488-001 | Feb 13, 2003 | ⤷ Get Started Free | ⤷ Get Started Free |
| Tolmar | ELIGARD KIT | leuprolide acetate | POWDER;SUBCUTANEOUS | 021488-001 | Feb 13, 2003 | ⤷ Get Started Free | ⤷ Get Started Free |
| Tolmar | ELIGARD KIT | leuprolide acetate | POWDER;SUBCUTANEOUS | 021488-001 | Feb 13, 2003 | ⤷ Get Started Free | ⤷ Get Started Free |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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