LEUPROLIDE ACETATE | N020011 | ABBVIE ENDOCRINE INC
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Attachment 3 - Draft Package Insert Proposed for Leuprolide acetate injection... FDA-2023-P-4357 Orbical Pharmaceutical Technologies Private Limited filed a citizen petition requesting FDA approval of additional strengths for leuprolide acetate injection, 1 mg/0.2 mL, with a draft package insert provided for the proposed formulation. The petition seeks regulatory suitability determination for t | Suitability | 2023-10-05 | Open | Orbical Pharmaceutical Technologies Private Limited |
Attachment III Draft Package Insert Proposed for Leuprolide acetate injection... FDA-2023-P-0609 Orbical Pharmaceutical Technologies Private Limited filed a citizen petition regarding leuprolide acetate injection, proposing a draft package insert as part of a suitability petition to establish specifications and standards for this generic drug product under the ANDA regulatory pathway. | Suitability | 2023-02-24 | Open | Orbical Pharmaceutical Technologies Private Limited |
Source: Regulations.gov. FDA citizen petitions matched by application number.
No patent or exclusivity listings for this strength.