FDA.reportPublic FDA data

Application 212026

Type
ANDA
Sponsor
AMTA

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001PROPRANOLOL HYDROCHLORIDEPROPRANOLOL HYDROCHLORIDECAPSULE, EXTENDED RELEASE;ORAL60MGNoNo
002PROPRANOLOL HYDROCHLORIDEPROPRANOLOL HYDROCHLORIDECAPSULE, EXTENDED RELEASE;ORAL80MGNoNo
003PROPRANOLOL HYDROCHLORIDEPROPRANOLOL HYDROCHLORIDECAPSULE, EXTENDED RELEASE;ORAL120MGNoNo
004PROPRANOLOL HYDROCHLORIDEPROPRANOLOL HYDROCHLORIDECAPSULE, EXTENDED RELEASE;ORAL160MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0527-4116Propranolol HydrochloridePropranolol HydrochlorideLannett Company, Inc.ANDACurrent
0527-4116Propranolol Hydrochloridepropranolol hydrochlorideLannett Company, Inc.ANDACurrent
0527-4116Propranolol Hydrochloridepropranolol hydrochlorideLannett Company, Inc.ANDACurrent
0527-4116Propranolol Hydrochloridepropranolol hydrochlorideLannett Company, Inc.ANDACurrent
0527-4117Propranolol Hydrochloridepropranolol hydrochlorideLannett Company, Inc.ANDACurrent
0527-4117Propranolol HydrochloridePropranolol HydrochlorideLannett Company, Inc.ANDACurrent
0527-4117Propranolol Hydrochloridepropranolol hydrochlorideLannett Company, Inc.ANDACurrent
0527-4117Propranolol Hydrochloridepropranolol hydrochlorideLannett Company, Inc.ANDACurrent
0527-4118Propranolol Hydrochloridepropranolol hydrochlorideLannett Company, Inc.ANDACurrent
0527-4118Propranolol Hydrochloridepropranolol hydrochlorideLannett Company, Inc.ANDACurrent
0527-4118Propranolol HydrochloridePropranolol HydrochlorideLannett Company, Inc.ANDACurrent
0527-4118Propranolol Hydrochloridepropranolol hydrochlorideLannett Company, Inc.ANDACurrent
0527-4119Propranolol Hydrochloridepropranolol hydrochlorideLannett Company, Inc.ANDACurrent
0527-4119Propranolol HydrochloridePropranolol HydrochlorideLannett Company, Inc.ANDACurrent
0527-4119Propranolol Hydrochloridepropranolol hydrochlorideLannett Company, Inc.ANDACurrent
0527-4119Propranolol Hydrochloridepropranolol hydrochlorideLannett Company, Inc.ANDACurrent
60760-576Propranolol Hydrochloridepropranolol hydrochlorideST. MARY'S MEDICAL PARK PHARMACYANDACurrent
70518-3465Propranolol Hydrochloridepropranolol hydrochlorideREMEDYREPACK INC.ANDACurrent
70518-3509Propranolol Hydrochloridepropranolol hydrochlorideREMEDYREPACK INC.ANDACurrent
70518-3552Propranolol Hydrochloridepropranolol hydrochlorideREMEDYREPACK INC.ANDACurrent
71335-1765Propranolol Hydrochloridepropranolol hydrochlorideBryant Ranch PrepackANDACurrent