FDA.reportPublic FDA data

Application 211173

Type
ANDA
Sponsor
CONCORD BIOTECH LTD

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001MYCOPHENOLIC ACIDMYCOPHENOLIC ACIDTABLET, DELAYED RELEASE;ORAL180MGNoNo
002MYCOPHENOLIC ACIDMYCOPHENOLIC ACIDTABLET, DELAYED RELEASE;ORAL360MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
68254-5001mycophenolic acidmycophenolic acidCONCORD BIOTECH LIMITEDANDACurrent
68254-5001mycophenolic acidmycophenolic acidCONCORD BIOTECH LIMITEDANDACurrent
68254-5001mycophenolic acidmycophenolic acidCONCORD BIOTECH LIMITEDANDACurrent
68254-5001mycophenolic acidmycophenolic acidCONCORD BIOTECH LIMITEDANDACurrent
68254-5002mycophenolic acidmycophenolic acidCONCORD BIOTECH LIMITEDANDACurrent
68254-5002mycophenolic acidmycophenolic acidCONCORD BIOTECH LIMITEDANDACurrent
68254-5002mycophenolic acidmycophenolic acidCONCORD BIOTECH LIMITEDANDACurrent
68254-5002mycophenolic acidmycophenolic acidCONCORD BIOTECH LIMITEDANDACurrent
70748-217mycophenolic acidmycophenolic acidLupin Pharmaceuticals, Inc.ANDACurrent
70748-217mycophenolic acidmycophenolic acidLupin Pharmaceuticals, Inc.ANDACurrent
70748-217mycophenolic acidmycophenolic acidLupin Pharmaceuticals, Inc.ANDACurrent
70748-217mycophenolic acidmycophenolic acidLupin Pharmaceuticals, Inc.ANDACurrent
70748-218mycophenolic acidmycophenolic acidLupin Pharmaceuticals, Inc.ANDACurrent
70748-218mycophenolic acidmycophenolic acidLupin Pharmaceuticals, Inc.ANDACurrent
70748-218mycophenolic acidmycophenolic acidLupin Pharmaceuticals, Inc.ANDACurrent
70748-218mycophenolic acidmycophenolic acidLupin Pharmaceuticals, Inc.ANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
76497ORIG 2023-11-07