LEUCOVORIN CALCIUM | A040147 | HOSPIRA INC
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Suitability Petition Completeness Assessment Correspondence from FDA CDER to ... FDA-2024-P-1441 Epic Pharma, LLC submitted a suitability petition under 21 C.F.R. §314.93(b) requesting permission to submit an Abbreviated New Drug Application for Leucovorin Calcium Injection in two strengths (200 mg/20 ml and 350 mg/35 ml). The FDA determined the petition complete and established an October 5, 2 | Suitability | 2024-04-05 | Open | — |
Suitability Petition from Gensia Laboratories, Inc. FDA-1997-P-0357 Gensia Laboratories, Inc. filed an ANDA suitability petition under Section 505(j)(2)(c) requesting approval to submit an abbreviated new drug application for Leucovorin Calcium Injection in a 300 mg strength, 10 mg/ml ready-to-use liquid formulation, which differs in strength and dosage form from th | Suitability | 2023-10-31 | Open | Gensia Laboratories |
Citizen Petition from Abbott Laboratories FDA-1993-P-0178 Abbott Laboratories filed this ANDA Suitability Petition under Federal Food, Drug and Cosmetic Act Section 505(j)(2)(c) requesting approval to submit an abbreviated new drug application for Leucovorin Calcium Injection, a ready-to-use sterile solution of 250 mg (10 mg/mL) in a 25 mL single-dose vial | Other | 2019-05-01 | Granted | Abbott Laboratories |
Citizen Petition from Abbott Laboratories FDA-1993-P-0178 Abbott Laboratories filed this citizen petition under Federal Food, Drug and Cosmetic Act Section 505(b)(2)(c) and CFR 314.93(d) requesting permission to submit an abbreviated new drug application (ANDA) for Leucovorin Calcium Injection, a ready-to-use sterile solution in a 50 mL pharmacy bulk packa | Other | 2019-05-01 | Granted | Abbott Laboratories |
Citizen Petition from Abbott Laboratories FDA-1993-P-0178 Abbott Laboratories' Hospital Products Division filed this ANDA suitability petition under Section 505(j)(2)(c) requesting approval to submit an abbreviated new drug application for Leucovorin Calcium Injection as a ready-to-use sterile solution in a 10 mL vial containing 100 mg, representing a chan | 505(q) | 2019-05-01 | Granted | Abbott Laboratories |
Source: Regulations.gov. FDA citizen petitions matched by application number.
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