FDA approved the original new drug application for LUPRON DEPOT-PED KIT on April 16, 1993, sponsored by ABBVIE ENDOCRINE INC. FDA marks 2 of the application’s 8 products discontinued and the other 6 still marketed. FDA has approved 4 efficacy supplements on the application since, the most recent on May 22, 2025.
- Application
- NDA020263
- Sponsor
- ABBVIE ENDOCRINE INC
- Original approval
- Review
- standard review
- Submission class
- Type 5 - New Formulation or New Manufacturer
- Active ingredient
- leuprolide acetate
Browse every approval whose brand starts with L, or the complete response letters FDA has published — the applications it did not approve.
Products under this application
| Ingredient and strength | Form | Route | Marketing status |
|---|---|---|---|
| leuprolide acetate 45MG | POWDER | INTRAMUSCULAR | Prescription |
| leuprolide acetate 11.25MG | POWDER | INTRAMUSCULAR | Prescription |
| leuprolide acetate 11.25MG | POWDER | INTRAMUSCULAR | Prescription |
| leuprolide acetate 3.75MG,7.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | POWDER | INTRAMUSCULAR | Discontinued |
| leuprolide acetate 30MG | POWDER | INTRAMUSCULAR | Prescription |
| leuprolide acetate 15MG | POWDER | INTRAMUSCULAR | Prescription |
| leuprolide acetate 7.5MG,7.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | POWDER | INTRAMUSCULAR | Discontinued |
| leuprolide acetate 7.5MG | POWDER | INTRAMUSCULAR | Prescription |
What “discontinued” means in FDA’s record
Drugs@FDA marks a product discontinued when it was never marketed, when it has been taken off the market, when it is made only for export, when it is made for military use, or when its approval was withdrawn for a reason other than safety or effectiveness. The record does not say which of those applies to a given product. The word on its own is not evidence that FDA found the drug unsafe.
Source: FDA, Drugs@FDA glossary of terms, under “Discontinued Drug Product”.
Approved efficacy supplements
An efficacy supplement is how a sponsor asks FDA to approve a change that needs clinical evidence — most often a new indication. FDA’s record gives each one a submission number, a date and a review priority. It does not say what any supplement approved, so neither does this page. The approval letter and label for each are on accessdata.fda.gov under the application number.
| Approved | Supplement | Review |
|---|---|---|
| S-36 | standard | |
| S-37 | standard | |
| S-53 | standard | |
| S-56 | standard |
FDA records other approved supplements on this application, by the class code it assigns them: Labeling 20 · Manufacturing (CMC) 16. Those are changes to the label or to how the drug is made rather than new clinical evidence, so they are counted here and not listed.
Source: FDA’s Drugs@FDA application file, via openFDA (export 2026-09-03). Every field on this page comes from that record.
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