LEUPROLIDE ACETATE | N019010 | ABBVIE ENDOCRINE INC
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Suitability Petition from Orbicular Pharmaceutical Technologies Private Limited FDA-2023-P-4357 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 | Open | Orbicular Pharmaceutical Technologies Private Limited |
Attachment 2 - Current labeling for LUPRON INJECTION, held by ABBVIE ENDOCRIN... FDA-2023-P-4357 Orbical Pharmaceutical Technologies Private Limited filed a suitability petition regarding LUPRON INJECTION (leuprolide acetate), an NDA product held by AbbVie Endocrine Inc. under NDA N019010, requesting FDA evaluation of the product's suitability for purposes related to the petitioner's proposed d | Suitability | 2023-10-05 | Open | Orbical Pharmaceutical Technologies Private Limited |
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 II LUPRON INJECTION re Suitability Petition from Orbical Pharmaceu... FDA-2023-P-0609 Orbical Pharmaceutical Technologies Private Limited filed a suitability petition regarding Lupron Injection, seeking FDA guidance on the regulatory pathway and manufacturing requirements for developing this drug product for the U.S. market. | Suitability | 2023-02-24 | Open | Orbical Pharmaceutical Technologies Private Limited |
Suitability Petition from Orbical Pharmaceutical Technologies Private Limited FDA-2023-P-0609 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 | 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 |
Citizen Petition from Hetero Labs Limited FDA-2018-P-4851 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 | Withdrawn | Hetero Labs Limited |
Source: Regulations.gov. FDA citizen petitions matched by application number.
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