LEUPROLIDE ACETATE | N020263 | ABBVIE ENDOCRINE INC
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Lachman Consultant Services, Inc. - Citizen Petition FDA-2013-P-1609 · 4 docket documents Lachman Consultant Services, Inc. filed this citizen petition on behalf of a client requesting that the FDA Commissioner determine whether the two-vial container closure system previously used for Lupron Depot (Leuprolide Acetate for Depot Suspension) Injection products under NDAs 19732, 20011, and | 505(q) | 2013-12-30 | Granted | — |
Lachman Consultant Services, Inc. - Citizen Petition FDA-2013-P-1510 · 5 docket documents Lachman Consultant Services, Inc., on behalf of a client, petitioned the FDA to determine whether the Lupron Depot-Ped dual-vial products (leuprolide acetate for depot suspension, NDA 020263, Product Nos. 003 and 004) were voluntarily withdrawn from sale for safety or effectiveness reasons, and requ | 505(q) | 2013-12-06 | Granted | — |
Source: Regulations.gov. FDA citizen petitions matched by application number.
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