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 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. Ten 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. Ten 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: | 2 |
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
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 | ⤷ Sign Up | ⤷ Sign Up |
| Tolmar | ELIGARD KIT | leuprolide acetate | POWDER;SUBCUTANEOUS | 021488-001 | Feb 13, 2003 | ⤷ Sign Up | ⤷ Sign Up |
| Tolmar | ELIGARD KIT | leuprolide acetate | POWDER;SUBCUTANEOUS | 021488-001 | Feb 13, 2003 | ⤷ Sign Up | ⤷ Sign Up |
| Tolmar | ELIGARD KIT | leuprolide acetate | POWDER;SUBCUTANEOUS | 021488-001 | Feb 13, 2003 | ⤷ Sign Up | ⤷ Sign Up |
| Tolmar | ELIGARD KIT | leuprolide acetate | POWDER;SUBCUTANEOUS | 021488-001 | Feb 13, 2003 | ⤷ Sign Up | ⤷ Sign Up |
| Tolmar | ELIGARD KIT | leuprolide acetate | POWDER;SUBCUTANEOUS | 021488-001 | Feb 13, 2003 | ⤷ Sign Up | ⤷ Sign Up |
| Tolmar | ELIGARD KIT | leuprolide acetate | POWDER;SUBCUTANEOUS | 021488-001 | Feb 13, 2003 | ⤷ Sign Up | ⤷ Sign Up |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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