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MYCOPHENOLATE MOFETIL HYDROCHLORIDE

ANDA

MYCOPHENOLATE MOFETIL HYDROCHLORIDE | A214283 | BPI LABS LLC

1 strength0 unique patents0 unique exclusivities

Reference Listed Drug: CELLCEPT(TE code: AP)

Citizen Petitions

1 petition (1 open) from Regulations.gov

Petition	Type	Filed	Status	Petitioner
Suitability Petition from BPI Labs, LLC FDA-2025-P-3510 BPI Labs, LLC submitted this suitability petition under section 505(j)(2)(C) of the FD&C Act requesting FDA determination that proposed additional strengths of Mycophenolate Mofetil for Injection (1 g/vial and 1.5 g/vial) are suitable for approval as a supplement to ANDA 214283, with CellCept (Mycop	Suitability	2025-09-04	Open	BPI Labs

Source: Regulations.gov. FDA citizen petitions matched by application number.

API Supply Chain1 active DMF

1 active API supplier hold Drug Master Files for this ingredient. Limited supplier base — potential supply chain risk.

CHUNGHWA CHEMICAL SYNTHESIS AND BIOTECH CO LTDMYCOPHENOLATE MOFETIL HYDROCHLORIDE ANHYDROUS

DMF 243722010

Source: FDA Drug Master Files (fda.gov). Type II API DMFs matched by ingredient.

Approval Letters

1 letter from Drugs@FDA

Date	Submission	Document
Jun 5, 2023	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — 500MG/VIAL

0 patents0 exclusivities▴

INJECTABLE;INJECTION | Approved: Jun 1, 2023

No patent or exclusivity listings for this strength.