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Last Updated: March 25, 2026

Details for New Drug Application (NDA): 216637


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NDA 216637 describes MYCOPHENOLATE SODIUM, which is a drug marketed by Accord Hlthcare, Alkem Labs Ltd, Apotex Inc, Aurobindo Pharma Ltd, Biocon Pharma, Concord Biotech Ltd, Fosun Wanbang, Rk Pharma, Teva Pharms Usa, Twi Pharms, and Yichang Humanwell, and is included in twelve NDAs. It is available from seventeen suppliers. Additional details are available on the MYCOPHENOLATE SODIUM profile page.

The generic ingredient in MYCOPHENOLATE SODIUM is mycophenolate sodium. There are thirty-eight drug master file entries for this compound. Eighteen suppliers are listed for this compound. Additional details are available on the mycophenolate sodium profile page.
Summary for 216637
Tradename:MYCOPHENOLATE SODIUM
Applicant:Fosun Wanbang
Ingredient:mycophenolate sodium
Patents:0
Pharmacology for NDA: 216637
Suppliers and Packaging for NDA: 216637
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
MYCOPHENOLATE SODIUM mycophenolate sodium TABLET, DELAYED RELEASE;ORAL 216637 ANDA Novugen Pharma (USA) LLC. 82293-012 82293-012-10 120 TABLET, DELAYED RELEASE in 1 BOTTLE (82293-012-10)
MYCOPHENOLATE SODIUM mycophenolate sodium TABLET, DELAYED RELEASE;ORAL 216637 ANDA Novugen Pharma (USA) LLC. 82293-013 82293-013-10 120 TABLET, DELAYED RELEASE in 1 BOTTLE (82293-013-10)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET, DELAYED RELEASE;ORALStrengthEQ 180MG BASE
Approval Date:May 29, 2024TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET, DELAYED RELEASE;ORALStrengthEQ 360MG BASE
Approval Date:May 29, 2024TE:ABRLD:No

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Preferred Citation:

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