FDA.reportPublic FDA data

Application 086831

Type
ANDA
Sponsor
MYLAN

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001CHLORTHALIDONECHLORTHALIDONETABLET;ORAL50MGNoYes
002CHLORTHALIDONECHLORTHALIDONETABLET;ORAL25MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0378-0213ChlorthalidonechlorthalidoneMylan Pharmaceuticals Inc.ANDACurrent
0378-0213ChlorthalidonechlorthalidoneMylan Pharmaceuticals Inc.ANDACurrent
0378-0213ChlorthalidonechlorthalidoneMylan Pharmaceuticals Inc.ANDACurrent
0378-0213ChlorthalidonechlorthalidoneMylan Pharmaceuticals Inc.ANDACurrent
0378-0222ChlorthalidonechlorthalidoneMylan Pharmaceuticals Inc.ANDACurrent
0378-0222ChlorthalidonechlorthalidoneMylan Pharmaceuticals Inc.ANDACurrent
0378-0222ChlorthalidonechlorthalidoneMylan Pharmaceuticals Inc.ANDACurrent
0378-0222ChlorthalidonechlorthalidoneMylan Pharmaceuticals Inc.ANDACurrent
21695-671ChlorthalidonechlorthalidoneRebel Distributors CorpANDACurrent
43353-922ChlorthalidonechlorthalidoneAphena Pharma Solutions - Tennessee, LLCANDACurrent
50090-0144ChlorthalidonechlorthalidoneA-S Medication SolutionsANDACurrent
50090-0144ChlorthalidonechlorthalidoneA-S Medication SolutionsANDACurrent
50090-0145ChlorthalidonechlorthalidoneA-S Medication SolutionsANDACurrent
50090-0145ChlorthalidonechlorthalidoneA-S Medication SolutionsANDACurrent
51079-058ChlorthalidonechlorthalidoneMylan Institutional Inc.ANDACurrent
51079-058ChlorthalidonechlorthalidoneMylan Institutional Inc.ANDACurrent
51079-058ChlorthalidonechlorthalidoneMylan Institutional Inc.ANDACurrent
55289-067ChlorthalidonechlorthalidonePD-Rx Pharmaceuticals, Inc.ANDACurrent
55289-067ChlorthalidonechlorthalidonePD-Rx Pharmaceuticals, Inc.ANDACurrent
55289-067ChlorthalidonechlorthalidonePD-Rx Pharmaceuticals, Inc.ANDACurrent
55289-067ChlorthalidonechlorthalidonePD-Rx Pharmaceuticals, Inc.ANDACurrent
55289-067ChlorthalidonechlorthalidonePD-Rx Pharmaceuticals, Inc.ANDACurrent
55289-067ChlorthalidonechlorthalidonePD-Rx Pharmaceuticals, Inc.ANDACurrent
55700-297ChlorthalidonechlorthalidoneLake Erie Medical DBA Quality Care Products LLCANDACurrent
63629-5259ChlorthalidonechlorthalidoneBryant Ranch PrepackANDACurrent
63629-5259ChlorthalidonechlorthalidoneBryant Ranch PrepackANDACurrent
63629-6347ChlorthalidonechlorthalidoneBryant Ranch PrepackANDACurrent
63629-6347ChlorthalidonechlorthalidoneBryant Ranch PrepackANDACurrent
70518-1683ChlorthalidonechlorthalidoneREMEDYREPACK INC.ANDACurrent
70518-1683ChlorthalidonechlorthalidoneREMEDYREPACK INC.ANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
85382SUPPL 2026-03-16