Details for New Drug Application (NDA): 021379
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The generic ingredient in ELIGARD KIT is leuprolide acetate. There are twenty-two drug master file entries for this compound. Eleven suppliers are listed for this compound. Additional details are available on the leuprolide acetate profile page.
Summary for 021379
Tradename: | ELIGARD KIT |
Applicant: | Tolmar Therap |
Ingredient: | leuprolide acetate |
Patents: | 1 |
Formulation / Manufacturing: | see details |
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 PHARMACEUTICALS 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) |
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: | See Plans and Pricing | Patent Expiration: | Oct 15, 2023 | Product Flag? | Y | Substance Flag? | Y | Delist Request? | |
Patented Use: | METHOD OF TREATING CANCER |
Expired US Patents for NDA 021379
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Tolmar Therap | ELIGARD KIT | leuprolide acetate | POWDER;SUBCUTANEOUS | 021379-001 | Jul 24, 2002 | See Plans and Pricing | See Plans and Pricing |
Tolmar Therap | ELIGARD KIT | leuprolide acetate | POWDER;SUBCUTANEOUS | 021379-001 | Jul 24, 2002 | See Plans and Pricing | See Plans and Pricing |
Tolmar Therap | ELIGARD KIT | leuprolide acetate | POWDER;SUBCUTANEOUS | 021379-001 | Jul 24, 2002 | See Plans and Pricing | See Plans and Pricing |
Tolmar Therap | ELIGARD KIT | leuprolide acetate | POWDER;SUBCUTANEOUS | 021379-001 | Jul 24, 2002 | See Plans and Pricing | See Plans and Pricing |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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