Mycophenolate mofetil hydrochloride
Mycophenolate mofetil hydrochloride: 1 brand, 8 generics; first approved Aug 12, 1998; generic available.
Generic available: 8 ANDA applications approved.
Brand (NDA) products
- ROCHE PALONDA 0507581998
Approved strengths under this FDA application. Strength Dosage form Route Status TE 500MG/VIAL INJECTABLE INJECTION Rx AP
Generic (ANDA) products (8)
- MYCOPHENOLATE MOFETIL HYDROCHLORIDEBPI LABSANDA 2142832023
Approved strengths under this FDA application. Strength Dosage form Route Status TE 500MG/VIAL INJECTABLE INJECTION Rx AP - MYCOPHENOLATE MOFETIL HYDROCHLORIDEONESOURCE SPECIALTYANDA 2163902022
Approved strengths under this FDA application. Strength Dosage form Route Status TE 500MG/VIAL INJECTABLE INJECTION Rx AP - MYCOPHENOLATE MOFETIL HYDROCHLORIDEAMNEALANDA 2113742021
Approved strengths under this FDA application. Strength Dosage form Route Status TE 500MG/VIAL INJECTABLE INJECTION Discontinued — - MYCOPHENOLATE MOFETIL HYDROCHLORIDEMEITHEALANDA 2121302021
Approved strengths under this FDA application. Strength Dosage form Route Status TE 500MG/VIAL INJECTABLE INJECTION Rx AP - MYCOPHENOLATE MOFETIL HYDROCHLORIDEZYDUS PHARMSANDA 2044732017
Approved strengths under this FDA application. Strength Dosage form Route Status TE 500MG/VIAL INJECTABLE INJECTION Rx AP - MYCOPHENOLATE MOFETIL HYDROCHLORIDEMYLAN LABS LTDANDA 2038592017
Approved strengths under this FDA application. Strength Dosage form Route Status TE 500MG/VIAL INJECTABLE INJECTION Rx AP - MYCOPHENOLATE MOFETIL HYDROCHLORIDERISINGANDA 2040432017
Approved strengths under this FDA application. Strength Dosage form Route Status TE 500MG/VIAL INJECTABLE INJECTION Rx AP - MYCOPHENOLATE MOFETIL HYDROCHLORIDEPH HEALTHANDA 2035752016
Approved strengths under this FDA application. Strength Dosage form Route Status TE 500MG/VIAL INJECTABLE INJECTION Rx AP
Listed patents
No patents are listed against this product in the Orange Book. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.
Approval history
Approvals span 1998–2023 across 9 FDA applications.
Mycophenolate mofetil hydrochloride: frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
Built directly from the FDA Orange Book data file (products, patents, and exclusivity). TE codes, RLD/RS flags, patent expirations, and exclusivity dates match the official FDA record. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.
Related FDA reference tools
- FDA Purple BookLicensed biologics, biosimilars, interchangeables, BLA records, and exclusivity dates.
- FDA BiosimilarsFDA-approved biosimilars and interchangeable biosimilars, by reference product.
- 510(k) Predicate DatabaseSearch FDA 510(k) clearances and map predicate-device lineage.
- FDA 483 DatabaseFDA Form 483 observations and inspection records by firm, date, and citation.
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