Last Updated: September 24, 2026

Details for New Drug Application (NDA): 216390


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NDA 216390 describes MYCOPHENOLATE MOFETIL HYDROCHLORIDE, which is a drug marketed by Amneal, Bpi Labs, Meitheal, Mylan Labs Ltd, Onesource Specialty, Ph Health, Rising, and Zydus Pharms, and is included in eight NDAs. It is available from six suppliers. Additional details are available on the MYCOPHENOLATE MOFETIL HYDROCHLORIDE profile page.

The generic ingredient in MYCOPHENOLATE MOFETIL HYDROCHLORIDE is mycophenolate mofetil hydrochloride. There is one drug master file entry for this compound. Seven suppliers are listed for this compound. Additional details are available on the mycophenolate mofetil hydrochloride profile page.
Summary for 216390
Tradename:MYCOPHENOLATE MOFETIL HYDROCHLORIDE
Applicant:Onesource Specialty
Ingredient:mycophenolate mofetil hydrochloride
Patents:0
Pharmacology for NDA: 216390
Suppliers and Packaging for NDA: 216390
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
MYCOPHENOLATE MOFETIL HYDROCHLORIDE mycophenolate mofetil hydrochloride INJECTABLE;INJECTION 216390 ANDA ARMAS PHARMACEUTICALS INC 72485-415 72485-415-04 4 VIAL in 1 CARTON (72485-415-04) / 20 mL in 1 VIAL
MYCOPHENOLATE MOFETIL HYDROCHLORIDE mycophenolate mofetil hydrochloride INJECTABLE;INJECTION 216390 ANDA ONESOURCE SPECIALTY PHARMA LIMITED 83270-000 83270-000-04 4 VIAL in 1 CARTON (83270-000-04) / 20 mL in 1 VIAL

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength500MG/VIAL
Approval Date:Dec 23, 2022TE:APRLD:No

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Preferred Citation:

Friedman, Yali. "DrugPatentWatch" DrugPatentWatch, thinkBiotech, 2026, www.DrugPatentWatch.com.
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