FDA.reportPublic FDA data

Application 070213

Type
ANDA
Sponsor
MYLAN

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001PROPRANOLOL HYDROCHLORIDEPROPRANOLOL HYDROCHLORIDETABLET;ORAL40MGNoNo
002PROPRANOLOL HYDROCHLORIDEPROPRANOLOL HYDROCHLORIDETABLET;ORAL10MGNoNo
003PROPRANOLOL HYDROCHLORIDEPROPRANOLOL HYDROCHLORIDETABLET;ORAL20MGNoNo
004PROPRANOLOL HYDROCHLORIDEPROPRANOLOL HYDROCHLORIDETABLET;ORAL80MGNoNo
005PROPRANOLOL HYDROCHLORIDEPROPRANOLOL HYDROCHLORIDETABLET;ORAL60MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0378-0182Propranolol Hydrochloridepropranolol hydrochlorideMylan Pharmaceuticals Inc.ANDACurrent
0378-0182Propranolol Hydrochloridepropranolol hydrochlorideMylan Pharmaceuticals Inc.ANDACurrent
0378-0182Propranolol Hydrochloridepropranolol hydrochlorideMylan Pharmaceuticals Inc.ANDACurrent
0378-0183Propranolol Hydrochloridepropranolol hydrochlorideMylan Pharmaceuticals Inc.ANDACurrent
0378-0183Propranolol Hydrochloridepropranolol hydrochlorideMylan Pharmaceuticals Inc.ANDACurrent
0378-0183Propranolol Hydrochloridepropranolol hydrochlorideMylan Pharmaceuticals Inc.ANDACurrent
0378-0184Propranolol Hydrochloridepropranolol hydrochlorideMylan Pharmaceuticals Inc.ANDACurrent
0378-0184Propranolol Hydrochloridepropranolol hydrochlorideMylan Pharmaceuticals Inc.ANDACurrent
0378-0184Propranolol Hydrochloridepropranolol hydrochlorideMylan Pharmaceuticals Inc.ANDACurrent
0378-0185Propranolol Hydrochloridepropranolol hydrochlorideMylan Pharmaceuticals Inc.ANDACurrent
0378-0185Propranolol Hydrochloridepropranolol hydrochlorideMylan Pharmaceuticals Inc.ANDACurrent
0378-0185Propranolol Hydrochloridepropranolol hydrochlorideMylan Pharmaceuticals Inc.ANDACurrent
0378-0187Propranolol Hydrochloridepropranolol hydrochlorideMylan Pharmaceuticals Inc.ANDACurrent
0378-0187Propranolol Hydrochloridepropranolol hydrochlorideMylan Pharmaceuticals Inc.ANDACurrent
0378-0187Propranolol Hydrochloridepropranolol hydrochlorideMylan Pharmaceuticals Inc.ANDACurrent
0615-2561Propranolol HydrochloridePropranolol HydrochlorideNCS HealthCare of KY, Inc dba Vangard LabsANDACurrent
0615-2562Propranolol HydrochloridePropranolol HydrochlorideNCS HealthCare of KY, Inc dba Vangard LabsANDACurrent
0615-2563Propranolol HydrochloridePropranolol HydrochlorideNCS HealthCare of KY, Inc dba Vangard LabsANDACurrent
43353-084Propranolol Hydrochloridepropranolol hydrochlorideAphena Pharma Solutions - Tennessee, LLCANDACurrent
43353-961Propranolol Hydrochloridepropranolol hydrochlorideAphena Pharma Solutions - Tennessee, LLCANDACurrent
51407-235Propranolol Hydrochloridepropranolol hydrochlorideGolden State Medical Supply, Inc.ANDACurrent
51407-235Propranolol Hydrochloridepropranolol hydrochlorideGolden State Medical Supply, Inc.ANDACurrent
51407-235Propranolol Hydrochloridepropranolol hydrochlorideGolden State Medical Supply Inc.ANDACurrent
51407-235Propranolol Hydrochloridepropranolol hydrochlorideGolden State Medical Supply, Inc.ANDACurrent
51407-236Propranolol Hydrochloridepropranolol hydrochlorideGolden State Medical Supply Inc.ANDACurrent
51407-236Propranolol Hydrochloridepropranolol hydrochlorideGolden State Medical Supply, Inc.ANDACurrent
51407-236Propranolol Hydrochloridepropranolol hydrochlorideGolden State Medical Supply, Inc.ANDACurrent
51407-236Propranolol Hydrochloridepropranolol hydrochlorideGolden State Medical Supply, Inc.ANDACurrent
51407-237Propranolol Hydrochloridepropranolol hydrochlorideGolden State Medical Supply Inc.ANDACurrent
51407-237Propranolol Hydrochloridepropranolol hydrochlorideGolden State Medical Supply, Inc.ANDACurrent
51407-237Propranolol Hydrochloridepropranolol hydrochlorideGolden State Medical Supply, Inc.ANDACurrent
51407-237Propranolol Hydrochloridepropranolol hydrochlorideGolden State Medical Supply, Inc.ANDACurrent
51407-238Propranolol Hydrochloridepropranolol hydrochlorideGolden State Medical Supply, Inc.ANDACurrent
51407-238Propranolol Hydrochloridepropranolol hydrochlorideGolden State Medical Supply, Inc.ANDACurrent
51407-238Propranolol Hydrochloridepropranolol hydrochlorideGolden State Medical Supply, Inc.ANDACurrent
51407-238Propranolol Hydrochloridepropranolol hydrochlorideGolden State Medical Supply Inc.ANDACurrent
51407-239Propranolol Hydrochloridepropranolol hydrochlorideGolden State Medical Supply Inc.ANDACurrent
51407-239Propranolol Hydrochloridepropranolol hydrochlorideGolden State Medical Supply, Inc.ANDACurrent
51407-239Propranolol Hydrochloridepropranolol hydrochlorideGolden State Medical Supply, Inc.ANDACurrent
51407-239Propranolol Hydrochloridepropranolol hydrochlorideGolden State Medical Supply, Inc.ANDACurrent
51655-318Propranolol HyrochloridePropranolol HydrochlorideNorthwind PharmaceuticalsANDACurrent
70518-1286Propranolol Hydrochloridepropranolol hydrochlorideREMEDYREPACK INC.ANDACurrent
70518-1286Propranolol Hydrochloridepropranolol hydrochlorideREMEDYREPACK INC.ANDACurrent
70518-1963Propranolol Hydrochloridepropranolol hydrochlorideREMEDYREPACK INC.ANDACurrent
71610-339Propranolol Hydrochloridepropranolol hydrochlorideAphena Pharma Solutions - Tennessee, LLCANDACurrent
71610-339Propranolol Hydrochloridepropranolol hydrochlorideAphena Pharma Solutions - Tennessee, LLCANDACurrent