Application 020263
- Type
- NDA
- Sponsor
- ABBVIE ENDOCRINE INC
Application Products
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 002 | LUPRON DEPOT-PED | LEUPROLIDE ACETATE | INJECTABLE;INJECTION | 7.5MG/VIAL | Yes | Yes |
| 003 | LUPRON DEPOT-PED | LEUPROLIDE ACETATE | INJECTABLE;INJECTION | 3.75MG/VIAL,7.5MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | Yes | No |
| 004 | LUPRON DEPOT-PED | LEUPROLIDE ACETATE | INJECTABLE;INJECTION | 7.5MG/VIAL,7.5MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | Yes | No |
| 005 | LUPRON DEPOT-PED | LEUPROLIDE ACETATE | INJECTABLE;INJECTION | 11.25MG/VIAL | Yes | Yes |
| 006 | LUPRON DEPOT-PED | LEUPROLIDE ACETATE | INJECTABLE;INJECTION | 15MG/VIAL | Yes | Yes |
| 007 | LUPRON DEPOT-PED | LEUPROLIDE ACETATE | INJECTABLE;INJECTION | 11.25MG/VIAL | Yes | Yes |
| 008 | LUPRON DEPOT-PED | LEUPROLIDE ACETATE | INJECTABLE;INJECTION | 30MG/VIAL | Yes | Yes |
| 009 | LUPRON DEPOT-PED KIT | LEUPROLIDE ACETATE | POWDER;INTRAMUSCULAR | 45MG | Yes | Yes |
NDC Listings For This Application
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 0074-2108 | Lupron Depot-PED | leuprolide acetate | AbbVie Inc. | NDA | Current |
| 0074-2108 | Lupron Depot-PED | leuprolide acetate | AbbVie Inc. | NDA | Current |
| 0074-2108 | Lupron Depot-PED | leuprolide acetate | AbbVie Inc. | NDA | Current |
| 0074-2108 | Lupron Depot-PED | leuprolide acetate | AbbVie Inc. | NDA | Current |
| 0074-2108 | Lupron Depot-PED | leuprolide acetate | AbbVie Inc. | NDA | Current |
| 0074-2108 | Lupron Depot-PED | leuprolide acetate | AbbVie Inc. | NDA | Current |
| 0074-2108 | Lupron Depot-PED | leuprolide acetate | AbbVie Inc. | NDA | Current |
| 0074-2282 | Lupron Depot-PED | leuprolide acetate | AbbVie Inc. | NDA | Current |
| 0074-2282 | Lupron Depot-PED | leuprolide acetate | AbbVie Inc. | NDA | Current |
| 0074-2282 | Lupron Depot-PED | leuprolide acetate | AbbVie Inc. | NDA | Current |
| 0074-2282 | Lupron Depot-PED | leuprolide acetate | AbbVie Inc. | NDA | Current |
| 0074-2282 | Lupron Depot-PED | leuprolide acetate | AbbVie Inc. | NDA | Current |
| 0074-2282 | Lupron Depot-PED | leuprolide acetate | AbbVie Inc. | NDA | Current |
| 0074-2282 | Lupron Depot-PED | leuprolide acetate | AbbVie Inc. | NDA | Current |
| 0074-2440 | Lupron Depot-PED | leuprolide acetate | AbbVie Inc. | NDA | Current |
| 0074-2440 | Lupron Depot-PED | leuprolide acetate | AbbVie Inc. | NDA | Current |
| 0074-2440 | Lupron Depot-PED | leuprolide acetate | AbbVie Inc. | NDA | Current |
| 0074-2440 | Lupron Depot-PED | leuprolide acetate | AbbVie Inc. | NDA | Current |
| 0074-2440 | Lupron Depot-PED | leuprolide acetate | AbbVie Inc. | NDA | Current |
| 0074-2440 | Lupron Depot-PED | leuprolide acetate | AbbVie Inc. | NDA | Current |
| 0074-2440 | Lupron Depot-PED | leuprolide acetate | AbbVie Inc. | NDA | Current |
| 0074-3779 | Lupron Depot-PED | leuprolide acetate | AbbVie Inc. | NDA | Current |
| 0074-3779 | Lupron Depot-PED | leuprolide acetate | AbbVie Inc. | NDA | Current |
| 0074-3779 | Lupron Depot-PED | leuprolide acetate | AbbVie Inc. | NDA | Current |
| 0074-3779 | Lupron Depot-PED | leuprolide acetate | AbbVie Inc. | NDA | Current |
| 0074-3779 | Lupron Depot-PED | leuprolide acetate | AbbVie Inc. | NDA | Current |
| 0074-3779 | Lupron Depot-PED | leuprolide acetate | AbbVie Inc. | NDA | Current |
| 0074-3779 | Lupron Depot-PED | leuprolide acetate | AbbVie Inc. | NDA | Current |
| 0074-9694 | Lupron Depot-PED | leuprolide acetate | AbbVie Inc. | NDA | Current |
| 0074-9694 | Lupron Depot-PED | leuprolide acetate | AbbVie Inc. | NDA | Current |
| 0074-9694 | Lupron Depot-PED | leuprolide acetate | AbbVie Inc. | NDA | Current |
| 0074-9694 | Lupron Depot-PED | leuprolide acetate | AbbVie Inc. | NDA | Current |
| 0074-9694 | Lupron Depot-PED | leuprolide acetate | AbbVie Inc. | NDA | Current |
| 0074-9694 | Lupron Depot-PED | leuprolide acetate | AbbVie Inc. | NDA | Current |
| 0074-9694 | Lupron Depot-PED | leuprolide acetate | AbbVie Inc. | NDA | Current |