FDA.reportPublic FDA data

Application 090321

Type
ANDA
Sponsor
ZYDUS PHARMS USA INC

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
65841-745PROPRANOLOL HYDROCHLORIDEPROPRANOLOL HYDROCHLORIDECadila Healthcare LimitedANDACurrent
65841-745PROPRANOLOL HYDROCHLORIDEPROPRANOLOL HYDROCHLORIDEZydus Lifesciences LimitedANDACurrent
65841-745PROPRANOLOL HYDROCHLORIDEPROPRANOLOL HYDROCHLORIDECadila Healthcare LimitedANDACurrent
65841-745PROPRANOLOL HYDROCHLORIDEPROPRANOLOL HYDROCHLORIDECadila Healthcare LimitedANDACurrent
65841-746PROPRANOLOL HYDROCHLORIDEPROPRANOLOL HYDROCHLORIDECadila Healthcare LimitedANDACurrent
65841-746PROPRANOLOL HYDROCHLORIDEPROPRANOLOL HYDROCHLORIDECadila Healthcare LimitedANDACurrent
65841-746PROPRANOLOL HYDROCHLORIDEPROPRANOLOL HYDROCHLORIDEZydus Lifesciences LimitedANDACurrent
65841-746PROPRANOLOL HYDROCHLORIDEPROPRANOLOL HYDROCHLORIDECadila Healthcare LimitedANDACurrent
65841-747PROPRANOLOL HYDROCHLORIDEPROPRANOLOL HYDROCHLORIDECadila Healthcare LimitedANDACurrent
65841-747PROPRANOLOL HYDROCHLORIDEPROPRANOLOL HYDROCHLORIDECadila Healthcare LimitedANDACurrent
65841-747PROPRANOLOL HYDROCHLORIDEPROPRANOLOL HYDROCHLORIDEZydus Lifesciences LimitedANDACurrent
65841-747PROPRANOLOL HYDROCHLORIDEPROPRANOLOL HYDROCHLORIDECadila Healthcare LimitedANDACurrent
65841-748PROPRANOLOL HYDROCHLORIDEPROPRANOLOL HYDROCHLORIDECadila Healthcare LimitedANDACurrent
65841-748PROPRANOLOL HYDROCHLORIDEPROPRANOLOL HYDROCHLORIDECadila Healthcare LimitedANDACurrent
65841-748PROPRANOLOL HYDROCHLORIDEPROPRANOLOL HYDROCHLORIDEZydus Lifesciences LimitedANDACurrent
65841-748PROPRANOLOL HYDROCHLORIDEPROPRANOLOL HYDROCHLORIDECadila Healthcare LimitedANDACurrent
68382-161PROPRANOLOL HYDROCHLORIDEPROPRANOLOL HYDROCHLORIDEZydus Pharmaceuticals USA Inc.ANDACurrent
68382-161PROPRANOLOL HYDROCHLORIDEPROPRANOLOL HYDROCHLORIDEZydus Pharmaceuticals (USA) Inc.ANDACurrent
68382-161PROPRANOLOL HYDROCHLORIDEPROPRANOLOL HYDROCHLORIDEZydus Pharmaceuticals (USA) Inc.ANDACurrent
68382-161PROPRANOLOL HYDROCHLORIDEPROPRANOLOL HYDROCHLORIDEZydus Pharmaceuticals (USA) Inc.ANDACurrent
68382-162PROPRANOLOL HYDROCHLORIDEPROPRANOLOL HYDROCHLORIDEZydus Pharmaceuticals USA Inc.ANDACurrent
68382-162PROPRANOLOL HYDROCHLORIDEPROPRANOLOL HYDROCHLORIDEZydus Pharmaceuticals (USA) Inc.ANDACurrent
68382-162PROPRANOLOL HYDROCHLORIDEPROPRANOLOL HYDROCHLORIDEZydus Pharmaceuticals (USA) Inc.ANDACurrent
68382-162PROPRANOLOL HYDROCHLORIDEPROPRANOLOL HYDROCHLORIDEZydus Pharmaceuticals (USA) Inc.ANDACurrent
68382-163PROPRANOLOL HYDROCHLORIDEPROPRANOLOL HYDROCHLORIDEZydus Pharmaceuticals USA Inc.ANDACurrent
68382-163PROPRANOLOL HYDROCHLORIDEPROPRANOLOL HYDROCHLORIDEZydus Pharmaceuticals (USA) Inc.ANDACurrent
68382-163PROPRANOLOL HYDROCHLORIDEPROPRANOLOL HYDROCHLORIDEZydus Pharmaceuticals (USA) Inc.ANDACurrent
68382-163PROPRANOLOL HYDROCHLORIDEPROPRANOLOL HYDROCHLORIDEZydus Pharmaceuticals (USA) Inc.ANDACurrent
68382-164PROPRANOLOL HYDROCHLORIDEPROPRANOLOL HYDROCHLORIDEZydus Pharmaceuticals USA Inc.ANDACurrent
68382-164PROPRANOLOL HYDROCHLORIDEPROPRANOLOL HYDROCHLORIDEZydus Pharmaceuticals (USA) Inc.ANDACurrent
68382-164PROPRANOLOL HYDROCHLORIDEPROPRANOLOL HYDROCHLORIDEZydus Pharmaceuticals (USA) Inc.ANDACurrent
68382-164PROPRANOLOL HYDROCHLORIDEPROPRANOLOL HYDROCHLORIDEZydus Pharmaceuticals (USA) Inc.ANDACurrent