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Last Updated: March 19, 2026

Details for New Drug Application (NDA): 214630


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NDA 214630 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 214630
Tradename:MYCOPHENOLATE SODIUM
Applicant:Biocon Pharma
Ingredient:mycophenolate sodium
Patents:0
Pharmacology for NDA: 214630
Suppliers and Packaging for NDA: 214630
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
MYCOPHENOLATE SODIUM mycophenolate sodium TABLET, DELAYED RELEASE;ORAL 214630 ANDA Biocon Pharma Inc. 70377-039 70377-039-11 120 TABLET, DELAYED RELEASE in 1 BOTTLE (70377-039-11)
MYCOPHENOLATE SODIUM mycophenolate sodium TABLET, DELAYED RELEASE;ORAL 214630 ANDA Biocon Pharma Inc. 70377-040 70377-040-11 120 TABLET, DELAYED RELEASE in 1 BOTTLE (70377-040-11)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET, DELAYED RELEASE;ORALStrengthEQ 180MG BASE
Approval Date:Nov 29, 2021TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET, DELAYED RELEASE;ORALStrengthEQ 360MG BASE
Approval Date:Nov 29, 2021TE:ABRLD:No

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Preferred Citation:

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