Details for New Drug Application (NDA): 020263
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NDA 020263 describes LUPRON DEPOT-PED KIT, which is a drug marketed by Abbvie Endocrine Inc and is included in one NDA. It is available from one supplier. There are two patents protecting this drug. Additional details are available on the LUPRON DEPOT-PED KIT profile page.
The generic ingredient in LUPRON DEPOT-PED 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.
The generic ingredient in LUPRON DEPOT-PED 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 020263
| Tradename: | LUPRON DEPOT-PED KIT |
| Applicant: | Abbvie Endocrine Inc |
| Ingredient: | leuprolide acetate |
| Patents: | 2 |
Medical Subject Heading (MeSH) Categories for 020263
Suppliers and Packaging for NDA: 020263
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| LUPRON DEPOT-PED KIT | leuprolide acetate | POWDER;INTRAMUSCULAR | 020263 | NDA | AbbVie Inc. | 0074-2108 | 0074-2108-03 | 1 KIT in 1 CARTON (0074-2108-03) * 1 mL in 1 SYRINGE * 1 SWAB in 1 PACKET |
| LUPRON DEPOT-PED KIT | leuprolide acetate | POWDER;INTRAMUSCULAR | 020263 | NDA | AbbVie Inc. | 0074-2282 | 0074-2282-03 | 1 KIT in 1 CARTON (0074-2282-03) * 1 mL in 1 SYRINGE * 1 SWAB in 1 PACKET |
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | POWDER;INTRAMUSCULAR | Strength | 7.5MG | ||||
| Approval Date: | Apr 16, 1993 | TE: | RLD: | Yes | |||||
Profile for product number 003
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | POWDER;INTRAMUSCULAR | Strength | 3.75MG,7.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | ||||
| Approval Date: | Apr 16, 1993 | TE: | RLD: | Yes | |||||
Profile for product number 004
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | POWDER;INTRAMUSCULAR | Strength | 7.5MG,7.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | ||||
| Approval Date: | Apr 16, 1993 | TE: | RLD: | Yes | |||||
Expired US Patents for NDA 020263
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