LEUPROLIDE ACETATE | N019010 | ABBVIE ENDOCRINE INC
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Suitability Petition from Orbicular Pharmaceutical Technologies Private Limited FDA-2023-P-4357 · 8 docket documents Orbicular Pharmaceutical Technologies Private Limited submitted a suitability petition under Section 505(j)(2)(C) of the FD&C Act requesting FDA approval to file an ANDA for leuprolide acetate injection, 1 mg/0.2 mL as a new strength, based on the reference listed drug LUPRON injection NDA N019010, | Suitability | 2023-10-05 | Granted | Orbicular Pharmaceutical Technologies Private Limited |
Suitability Petition from Orbical Pharmaceutical Technologies Private Limited FDA-2023-P-0609 · 6 docket documents Orbical Pharmaceutical Technologies Private Limited submitted this suitability petition under Section 505(j)(2)(C) of the FD&C Act requesting FDA approval to file an ANDA for Leuprolide acetate injection, 1 mg/0.2 mL as a single-dose prefilled syringe with the same concentration but different fill v | Suitability | 2023-02-24 | Withdrawn | Orbical Pharmaceutical Technologies Private Limited |
Citizen Petition from Hetero Labs Limited FDA-2018-P-4851 · 9 docket documents Hetero Labs Limited filed a citizen petition on December 20, 2018, requesting that the FDA Commissioner determine whether the reference listed drug Lupron (Leuprolide Acetate Injection 14mg/2.8mL), NDA 019010, held by Abbvie Endocrine Inc., was voluntarily withdrawn for safety or effectiveness reaso | 505(q) | 2018-12-21 | Granted | Hetero Labs Limited |
Source: Regulations.gov. FDA citizen petitions matched by application number.
No patent or exclusivity listings for this strength.