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Last Updated: March 29, 2024

Details for New Drug Application (NDA): 214376


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NDA 214376 describes MYCOPHENOLIC SODIUM, which is a drug marketed by Accord Hlthcare, Airis Pharma Pvt Ltd, Alkem Labs Ltd, Amta, Apotex Inc, Biocon Pharma, Concord Biotech Ltd, Rk Pharma, Teva Pharms Usa, and Twi Pharms, and is included in ten NDAs. It is available from seventeen suppliers. Additional details are available on the MYCOPHENOLIC SODIUM profile page.

The generic ingredient in MYCOPHENOLIC SODIUM is mycophenolic sodium. There are seventeen drug master file entries for this compound. Eighteen suppliers are listed for this compound. Additional details are available on the mycophenolic sodium profile page.
Summary for 214376
Tradename:MYCOPHENOLIC SODIUM
Applicant:Amta
Ingredient:mycophenolic sodium
Patents:0
Pharmacology for NDA: 214376
Suppliers and Packaging for NDA: 214376
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
MYCOPHENOLIC SODIUM mycophenolic sodium TABLET, DELAYED RELEASE;ORAL 214376 ANDA Slate Run Pharmaceuticals, LLC 70436-172 70436-172-23 120 TABLET, DELAYED RELEASE in 1 BOTTLE (70436-172-23)
MYCOPHENOLIC SODIUM mycophenolic sodium TABLET, DELAYED RELEASE;ORAL 214376 ANDA Slate Run Pharmaceuticals, LLC 70436-173 70436-173-23 120 TABLET, DELAYED RELEASE in 1 BOTTLE (70436-173-23)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET, DELAYED RELEASE;ORALStrengthEQ 180MG BASE
Approval Date:Feb 10, 2021TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET, DELAYED RELEASE;ORALStrengthEQ 360MG BASE
Approval Date:Feb 10, 2021TE:ABRLD:No

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