FDA.reportPublic FDA data

Application 018716

Type
NDA
Sponsor
CNTY LINE PHARMS

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001TRANDATELABETALOL HYDROCHLORIDETABLET;ORAL100MGYesNo
002TRANDATELABETALOL HYDROCHLORIDETABLET;ORAL200MGYesNo
003TRANDATELABETALOL HYDROCHLORIDETABLET;ORAL300MGYesNo
004TRANDATELABETALOL HYDROCHLORIDETABLET;ORAL400MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**YesNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
43199-037Labetalol Hydrochloridelabetalol hydrochlorideCounty Line Pharmaceuticals LLCNDACurrent
43199-038Labetalol Hydrochloridelabetalol hydrochlorideCounty Line Pharmaceuticals LLCNDACurrent
43199-039Labetalol Hydrochloridelabetalol hydrochlorideCounty Line Pharmaceuticals LLCNDACurrent
47781-552Labetalol Hydrochloridelabetalol hydrochlorideAlvogen Inc.NDACurrent
47781-552Labetalol Hydrochloridelabetalol hydrochlorideAlvogen Inc.NDACurrent
47781-552Labetalol Hydrochloridelabetalol hydrochlorideAlvogen Inc.NDACurrent
47781-552Labetalol Hydrochloridelabetalol hydrochlorideAlvogen Inc.NDACurrent
47781-552Labetalol Hydrochloridelabetalol hydrochlorideAlvogen Inc.NDACurrent
47781-553Labetalol Hydrochloridelabetalol hydrochlorideAlvogen Inc.NDACurrent
47781-553Labetalol Hydrochloridelabetalol hydrochlorideAlvogen Inc.NDACurrent
47781-553Labetalol Hydrochloridelabetalol hydrochlorideAlvogen Inc.NDACurrent
47781-553Labetalol Hydrochloridelabetalol hydrochlorideAlvogen Inc.NDACurrent
47781-553Labetalol Hydrochloridelabetalol hydrochlorideAlvogen Inc.NDACurrent
47781-554Labetalol Hydrochloridelabetalol hydrochlorideAlvogen Inc.NDACurrent
47781-554Labetalol Hydrochloridelabetalol hydrochlorideAlvogen Inc.NDACurrent
47781-554Labetalol Hydrochloridelabetalol hydrochlorideAlvogen Inc.NDACurrent
47781-554Labetalol Hydrochloridelabetalol hydrochlorideAlvogen Inc.NDACurrent
47781-554Labetalol Hydrochloridelabetalol hydrochlorideAlvogen Inc.NDACurrent
50090-2428Labetalol Hydrochloridelabetalol hydrochlorideA-S Medication SolutionsNDACurrent
50090-3584Labetalol Hydrochloridelabetalol hydrochlorideA-S Medication SolutionsNDACurrent
50090-4149Labetalol Hydrochloridelabetalol hydrochlorideA-S Medication SolutionsNDACurrent
50090-4149Labetalol Hydrochloridelabetalol hydrochlorideA-S Medication SolutionsNDACurrent
60760-231Labetalol Hydrochloridelabetalol hydrochlorideSt. Mary's Medical Park PharmacyNDACurrent
65483-391Trandatelabetalol hydrochloridePrometheus Laboratories Inc.NDACurrent
65483-392Trandatelabetalol hydrochloridePrometheus Laboratories Inc.NDACurrent
65483-393Trandatelabetalol hydrochloridePrometheus Laboratories Inc.NDACurrent
68071-3180Labetalol Hydrochloridelabetalol hydrochlorideNuCare Pharmaceuticals, Inc.NDACurrent
70518-0027Labetalol Hydrochloridelabetalol hydrochlorideREMEDYREPACK INC.NDACurrent
70518-1887Labetalol Hydrochloridelabetalol hydrochlorideREMEDYREPACK INC.NDACurrent
70518-1887Labetalol Hydrochloridelabetalol hydrochlorideREMEDYREPACK INC.NDACurrent
71335-0118Labetalol Hydrochloridelabetalol hydrochlorideBryant Ranch PrepackNDACurrent
71335-0118Labetalol Hydrochloridelabetalol hydrochlorideBryant Ranch PrepackNDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
78269SUPPL 2024-04-26
78268SUPPL 2024-04-26
73504SUPPL 2023-02-15
73488SUPPL 2023-02-14
1046SUPPL2010-11-30
33572SUPPL2010-11-22
15114SUPPL2003-05-29