LEUCOVORIN CALCIUM | A040347 | HIKMA PHARMACEUTICALS USA INC
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Citizen Petition from Epic Pharma, LLC FDA-2024-P-4494 · 6 docket documents Epic Pharma, LLC requests that the FDA Commissioner determine whether Leucovorin Calcium Injection, Eq 10 mg Base/mL (ANDA 040347) held by Hikma Pharmaceuticals USA Inc. was voluntarily withdrawn or withdrawn for safety or effectiveness reasons under Section 505(j)(2)(C) of the FD&C Act and 21 CFR 3 | 505(q) | 2024-09-26 | Withdrawn | Epic Pharma, LLC |
Citizen Petition from Lachman Consulting Services, Inc. FDA-2016-P-2337 · 6 docket documents Lachman Consulting Services, Inc. filed this citizen petition pursuant to section 505(j)(2)(C) of the Federal Food, Drug, and Cosmetic Act requesting that the FDA declare Leucovorin Calcium Injection USP (preservative free) in strengths of 50 mg/5 mL, 100 mg/10 mL, 200 mg/20 mL, and 350 mg/35 mL sui | Other | 2016-08-01 | Withdrawn | Lachman Consulting Services, Inc. |
Source: Regulations.gov. FDA citizen petitions matched by application number.
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