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 one supplier. There are two 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. Fourteen 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. Fourteen 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: | 2 |
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: | 11,771,841 | Patent Expiration: | Dec 22, 2041 | Product Flag? | Y | Substance Flag? | Y | Delist Request? | |
| Patent: | 11,931,559 | Patent Expiration: | Dec 22, 2041 | Product Flag? | Substance Flag? | Y | Delist Request? | ||
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 | 6,395,293 | ⤷ Try for Free |
| Tolmar | ELIGARD KIT | leuprolide acetate | POWDER;SUBCUTANEOUS | 021379-001 | Jul 24, 2002 | 5,324,519 | ⤷ Try for Free |
| Tolmar | ELIGARD KIT | leuprolide acetate | POWDER;SUBCUTANEOUS | 021379-001 | Jul 24, 2002 | 4,938,763 | ⤷ Try for Free |
| Tolmar | ELIGARD KIT | leuprolide acetate | POWDER;SUBCUTANEOUS | 021379-001 | Jul 24, 2002 | RE37950 | ⤷ Try for Free |
| Tolmar | ELIGARD KIT | leuprolide acetate | POWDER;SUBCUTANEOUS | 021379-001 | Jul 24, 2002 | 5,739,176 | ⤷ Try for Free |
| Tolmar | ELIGARD KIT | leuprolide acetate | POWDER;SUBCUTANEOUS | 021379-001 | Jul 24, 2002 | 9,283,282 | ⤷ Try for Free |
| Tolmar | ELIGARD KIT | leuprolide acetate | POWDER;SUBCUTANEOUS | 021379-001 | Jul 24, 2002 | 5,733,950 | ⤷ Try for Free |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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