FDA.report

Application 078703

Type
ANDA
Sponsor
ADARE PHARMS INC

Related Records

Application Products

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

NDCNameNonproprietary nameLabelerMarketing categoryStatus
42291-522propranolol hydrochloridepropranolol hydrochlorideAvKARE, Inc.ANDACurrent
42291-522propranolol hydrochloridepropranolol hydrochlorideAvKARE, Inc.ANDACurrent
42291-522propranolol hydrochloridepropranolol hydrochlorideAvKAREANDACurrent
42291-523propranolol hydrochloridepropranolol hydrochlorideAvKARE, Inc.ANDACurrent
42291-523propranolol hydrochloridepropranolol hydrochlorideAvKARE, Inc.ANDACurrent
42291-523propranolol hydrochloridepropranolol hydrochlorideAvKAREANDACurrent
42291-524propranolol hydrochloridepropranolol hydrochlorideAvKARE, Inc.ANDACurrent
42291-524propranolol hydrochloridepropranolol hydrochlorideAvKARE, Inc.ANDACurrent
42291-524propranolol hydrochloridepropranolol hydrochlorideAvKAREANDACurrent
42291-525propranolol hydrochloridepropranolol hydrochlorideAvKARE, Inc.ANDACurrent
42291-525propranolol hydrochloridepropranolol hydrochlorideAvKARE, Inc.ANDACurrent
42291-525propranolol hydrochloridepropranolol hydrochlorideAvKAREANDACurrent
50090-1501propranolol hydrochloridepropranolol hydrochlorideA-S Medication SolutionsANDACurrent
50090-1501propranolol hydrochloridepropranolol hydrochlorideA-S Medication SolutionsANDACurrent
50090-1501propranolol hydrochloridepropranolol hydrochlorideA-S Medication SolutionsANDACurrent
51991-817propranolol hydrochloridepropranolol hydrochlorideBreckenridge Pharmaceutical, Inc.ANDACurrent
51991-817propranolol hydrochloridepropranolol hydrochlorideBreckenridge Pharmaceutical, Inc.ANDACurrent
51991-817propranolol hydrochloridepropranolol hydrochlorideBreckenridge Pharmaceutical, Inc.ANDACurrent
51991-818propranolol hydrochloridepropranolol hydrochlorideBreckenridge Pharmaceutical, Inc.ANDACurrent
51991-818propranolol hydrochloridepropranolol hydrochlorideBreckenridge Pharmaceutical, Inc.ANDACurrent
51991-818propranolol hydrochloridepropranolol hydrochlorideBreckenridge Pharmaceutical, Inc.ANDACurrent
51991-819propranolol hydrochloridepropranolol hydrochlorideBreckenridge Pharmaceutical, Inc.ANDACurrent
51991-819propranolol hydrochloridepropranolol hydrochlorideBreckenridge Pharmaceutical, Inc.ANDACurrent
51991-819propranolol hydrochloridepropranolol hydrochlorideBreckenridge Pharmaceutical, Inc.ANDACurrent
51991-820propranolol hydrochloridepropranolol hydrochlorideBreckenridge Pharmaceutical, Inc.ANDACurrent
51991-820propranolol hydrochloridepropranolol hydrochlorideBreckenridge Pharmaceutical, Inc.ANDACurrent
51991-820propranolol hydrochloridepropranolol hydrochlorideBreckenridge Pharmaceutical, Inc.ANDACurrent
55700-121propranolol hydrochloridepropranolol hydrochlorideLake Erie Medical DBA Quality Care Products LLCANDACurrent
55700-940propranolol hydrochloridepropranolol hydrochlorideQuality Care Products, LLCANDACurrent
55700-940propranolol hydrochloridepropranolol hydrochlorideQuality Care Products, LLCANDACurrent
60687-215Propranolol HydrochloridePropranolol HydrochlorideAmerican Health PackagingANDACurrent
60687-215Propranolol HydrochloridePropranolol HydrochlorideAmerican Health PackagingANDACurrent
60687-215Propranolol HydrochloridePropranolol HydrochlorideAmerican Health PackagingANDACurrent
60687-226Propranolol HydrochloridePropranolol HydrochlorideAmerican Health PackagingANDACurrent
60687-226Propranolol HydrochloridePropranolol HydrochlorideAmerican Health PackagingANDACurrent
60687-226Propranolol HydrochloridePropranolol HydrochlorideAmerican Health PackagingANDACurrent
61919-794Propranolol HCL ERPropranolol HCL ERDirect RxANDACurrent
63629-2069propranolol hydrochloridepropranolol hydrochlorideBryant Ranch PrepackANDACurrent
63629-2069propranolol hydrochloridepropranolol hydrochlorideBryant Ranch PrepackANDACurrent
63629-2070propranolol hydrochloridepropranolol hydrochlorideBryant Ranch PrepackANDACurrent
63629-2070propranolol hydrochloridepropranolol hydrochlorideBryant Ranch PrepackANDACurrent
63629-2071propranolol hydrochloridepropranolol hydrochlorideBryant Ranch PrepackANDACurrent
63629-2071propranolol hydrochloridepropranolol hydrochlorideBryant Ranch PrepackANDACurrent
63629-2072propranolol hydrochloridepropranolol hydrochlorideBryant Ranch PrepackANDACurrent
63629-2072propranolol hydrochloridepropranolol hydrochlorideBryant Ranch PrepackANDACurrent
63629-9282propranolol hydrochloridepropranolol hydrochlorideBryant Ranch PrepackANDACurrent
70518-1463propranolol hydrochloridepropranolol hydrochlorideREMEDYREPACK INC.ANDACurrent
70518-1463propranolol hydrochloridepropranolol hydrochlorideREMEDYREPACK INC.ANDACurrent
70518-1463propranolol hydrochloridepropranolol hydrochlorideREMEDYREPACK INC.ANDACurrent
70518-1463propranolol hydrochloridepropranolol hydrochlorideREMEDYREPACK INC.ANDACurrent
70518-1463propranolol hydrochloridepropranolol hydrochlorideREMEDYREPACK INC.ANDACurrent
70518-1654propranolol hydrochloridepropranolol hydrochlorideREMEDYREPACK INC.ANDACurrent
70518-1654propranolol hydrochloridepropranolol hydrochlorideREMEDYREPACK INC.ANDACurrent
70518-1654propranolol hydrochloridepropranolol hydrochlorideREMEDYREPACK INC.ANDACurrent
70518-1831propranolol hydrochloridepropranolol hydrochlorideREMEDYREPACK INC.ANDACurrent
71335-0234propranolol hydrochloridepropranolol hydrochlorideBryant Ranch PrepackANDACurrent
71335-0234propranolol hydrochloridepropranolol hydrochlorideBryant Ranch PrepackANDACurrent
71335-0234propranolol hydrochloridepropranolol hydrochlorideBryant Ranch PrepackANDACurrent
72189-018PROPRANOLOL HYDROCHLORIDEPROPRANOLOL HYDROCHLORIDEDirect_RxANDACurrent