Requests that the FDA, pursuant to Section 505(j)(2)(C) of the FD&C Act and 21 CFR 314.93, determination that the proposed additional strengths of Mycophenolate Mofetil for Injection, 1 g/vial and 1.5 g/vial, are suitable for approval as a supplemental submission to ANDA 214283, for which CellCept (Mycophenolate Mofetil for Injection, 500 mg/vial) is the designated reference listed drug | Federal Regulations · Congress.wiki

Nonrulemaking

FDA

FDA-2025-P-3510

Requests that the FDA, pursuant to Section 505(j)(2)(C) of the FD&C Act and 21 CFR 314.93, determination that the proposed additional strengths of Mycophenolate Mofetil for Injection, 1 g/vial and 1.5 g/vial, are suitable for approval as a supplemental submission to ANDA 214283, for which CellCept (Mycophenolate Mofetil for Injection, 500 mg/vial) is the designated reference listed drug

Documents

Comments

Description

CLOSED

Key Dates

Comment Period OpensSep 4, 2025

Documents

Type	Title	Posted	Comments	Status
Other	Response Letter from FDA CDER to BPI Labs, LLC	Feb 17, 2026	--

Keywords

CDER

Suitability Petition

BPI Labs, LLC

Requests that the FDA, pursuant to

Section 505(j)(2)(C) of the FD&C Act and

21 CFR 314.93, determination that the proposed

additional strengths of Mycophenolate Mofetil

for Injection, 1 g/vial and 1.5 g/vial, are

Data from Regulations.gov