FDA.reportPublic FDA data

Application 018553

Type
NDA
Sponsor
ANI PHARMS INC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001INDERAL LAPROPRANOLOL HYDROCHLORIDECAPSULE, EXTENDED RELEASE;ORAL160MGYesYes
002INDERAL LAPROPRANOLOL HYDROCHLORIDECAPSULE, EXTENDED RELEASE;ORAL80MGYesNo
003INDERAL LAPROPRANOLOL HYDROCHLORIDECAPSULE, EXTENDED RELEASE;ORAL120MGYesNo
004INDERAL LAPROPRANOLOL HYDROCHLORIDECAPSULE, EXTENDED RELEASE;ORAL60MGYesNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
10544-286Propranolol Hydrochloridepropranolol hydrochlorideBlenheim Pharmacal, Inc.NDA AUTHORIZED GENERICCurrent
43478-900Propranolol Hydrochloridepropranolol hydrochlorideRouses Point PharmNDA AUTHORIZED GENERICCurrent
43478-901Propranolol Hydrochloridepropranolol hydrochlorideRouses Point PharmNDA AUTHORIZED GENERICCurrent
43478-902Propranolol Hydrochloridepropranolol hydrochlorideRouses Point PharmNDA AUTHORIZED GENERICCurrent
43478-903Propranolol Hydrochloridepropranolol hydrochlorideRouses Point PharmNDA AUTHORIZED GENERICCurrent
50436-0902Propranolol Hydrochloridepropranolol hydrochlorideUnit Dose ServicesNDA AUTHORIZED GENERICCurrent
60760-538Propranolol Hydrochloridepropranolol hydrochlorideSt. Mary's Medical Park PharmacyNDA AUTHORIZED GENERICCurrent
61919-488Propranolol hcl ERPropranolol hcl ERDirect RxNDA AUTHORIZED GENERICCurrent
61919-488Propranolol hcl ERPropranolol hcl ERDirect RxNDA AUTHORIZED GENERICCurrent
61919-489PROPRANOLOL HYDROCHLORIDE ERPROPRANOLOL HYDROCHLORIDE ERDirect RxNDA AUTHORIZED GENERICCurrent
61919-489PROPRANOLOL HYDROCHLORIDE ERPROPRANOLOL HYDROCHLORIDE ERDirect RxNDA AUTHORIZED GENERICCurrent
62559-520INDERALpropranolol hydrochlorideANI Pharmaceuticals, Inc.NDACurrent
62559-520INDERALpropranolol hydrochlorideANI Pharmaceuticals, Inc.NDACurrent
62559-520INDERALpropranolol hydrochlorideANI Pharmaceuticals, Inc.NDACurrent
62559-521INDERALpropranolol hydrochlorideANI Pharmaceuticals, Inc.NDACurrent
62559-521INDERALpropranolol hydrochlorideANI Pharmaceuticals, Inc.NDACurrent
62559-521INDERALpropranolol hydrochlorideANI Pharmaceuticals, Inc.NDACurrent
62559-522INDERALpropranolol hydrochlorideANI Pharmaceuticals, Inc.NDACurrent
62559-522INDERALpropranolol hydrochlorideANI Pharmaceuticals, Inc.NDACurrent
62559-522INDERALpropranolol hydrochlorideANI Pharmaceuticals, Inc.NDACurrent
62559-523INDERALpropranolol hydrochlorideANI Pharmaceuticals, Inc.NDACurrent
62559-523INDERALpropranolol hydrochlorideANI Pharmaceuticals, Inc.NDACurrent
62559-523INDERALpropranolol hydrochlorideANI Pharmaceuticals, Inc.NDACurrent
62559-530Propranolol Hydrochloridepropranolol hydrochlorideANI Pharmaceuticals, Inc.NDA AUTHORIZED GENERICCurrent
62559-530Propranolol Hydrochloridepropranolol hydrochlorideANI Pharmaceuticals, Inc.NDA AUTHORIZED GENERICCurrent
62559-530Propranolol Hydrochloridepropranolol hydrochlorideANI Pharmaceuticals, Inc.NDA AUTHORIZED GENERICCurrent
62559-530Propranolol Hydrochloridepropranolol hydrochlorideANI Pharmaceuticals, Inc.NDA AUTHORIZED GENERICCurrent
62559-530Propranolol Hydrochloridepropranolol hydrochlorideANI Pharmaceuticals, Inc.NDA AUTHORIZED GENERICCurrent
62559-531Propranolol Hydrochloridepropranolol hydrochlorideANI Pharmaceuticals, Inc.NDA AUTHORIZED GENERICCurrent
62559-531Propranolol Hydrochloridepropranolol hydrochlorideANI Pharmaceuticals, Inc.NDA AUTHORIZED GENERICCurrent
62559-531Propranolol Hydrochloridepropranolol hydrochlorideANI Pharmaceuticals, Inc.NDA AUTHORIZED GENERICCurrent
62559-531Propranolol Hydrochloridepropranolol hydrochlorideANI Pharmaceuticals, Inc.NDA AUTHORIZED GENERICCurrent
62559-531Propranolol Hydrochloridepropranolol hydrochlorideANI Pharmaceuticals, Inc.NDA AUTHORIZED GENERICCurrent
62559-532Propranolol Hydrochloridepropranolol hydrochlorideANI Pharmaceuticals, Inc.NDA AUTHORIZED GENERICCurrent
62559-532Propranolol Hydrochloridepropranolol hydrochlorideANI Pharmaceuticals, Inc.NDA AUTHORIZED GENERICCurrent
62559-532Propranolol Hydrochloridepropranolol hydrochlorideANI Pharmaceuticals, Inc.NDA AUTHORIZED GENERICCurrent
62559-532Propranolol Hydrochloridepropranolol hydrochlorideANI Pharmaceuticals, Inc.NDA AUTHORIZED GENERICCurrent
62559-532Propranolol Hydrochloridepropranolol hydrochlorideANI Pharmaceuticals, Inc.NDA AUTHORIZED GENERICCurrent
62559-533Propranolol Hydrochloridepropranolol hydrochlorideANI Pharmaceuticals, Inc.NDA AUTHORIZED GENERICCurrent
62559-533Propranolol Hydrochloridepropranolol hydrochlorideANI Pharmaceuticals, Inc.NDA AUTHORIZED GENERICCurrent
62559-533Propranolol Hydrochloridepropranolol hydrochlorideANI Pharmaceuticals, Inc.NDA AUTHORIZED GENERICCurrent
62559-533Propranolol Hydrochloridepropranolol hydrochlorideANI Pharmaceuticals, Inc.NDA AUTHORIZED GENERICCurrent
62559-533Propranolol Hydrochloridepropranolol hydrochlorideANI Pharmaceuticals, Inc.NDA AUTHORIZED GENERICCurrent
63629-1968Propranolol Hydrochloridepropranolol hydrochlorideBryant Ranch PrepackNDA AUTHORIZED GENERICCurrent
63629-1968Propranolol Hydrochloridepropranolol hydrochlorideBryant Ranch PrepackNDA AUTHORIZED GENERICCurrent
63629-7176Propranolol Hydrochloridepropranolol hydrochlorideBryant Ranch PrepackNDA AUTHORIZED GENERICCurrent
71335-0387Propranolol Hydrochloridepropranolol hydrochlorideBryant Ranch PrepackNDA AUTHORIZED GENERICCurrent
71335-0387Propranolol Hydrochloridepropranolol hydrochlorideBryant Ranch PrepackNDA AUTHORIZED GENERICCurrent
71335-0731Propranolol Hydrochloridepropranolol hydrochlorideBryant Ranch PrepackNDA AUTHORIZED GENERICCurrent
71335-0731Propranolol Hydrochloridepropranolol hydrochlorideBryant Ranch PrepackNDA AUTHORIZED GENERICCurrent
71335-0731Propranolol Hydrochloridepropranolol hydrochlorideBryant Ranch PrepackNDA AUTHORIZED GENERICCurrent
71335-0731Propranolol Hydrochloridepropranolol hydrochlorideBryant Ranch PrepackNDA AUTHORIZED GENERICCurrent
71335-0731Propranolol Hydrochloridepropranolol hydrochlorideBryant Ranch PrepackNDA AUTHORIZED GENERICCurrent
71335-0907Propranolol Hydrochloridepropranolol hydrochlorideBryant Ranch PrepackNDA AUTHORIZED GENERICCurrent
71335-0907Propranolol Hydrochloridepropranolol hydrochlorideBryant Ranch PrepackNDA AUTHORIZED GENERICCurrent
71335-0907Propranolol Hydrochloridepropranolol hydrochlorideBryant Ranch PrepackNDA AUTHORIZED GENERICCurrent
71335-0907Propranolol Hydrochloridepropranolol hydrochlorideBryant Ranch PrepackNDA AUTHORIZED GENERICCurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
76535SUPPL 2023-11-08
76534SUPPL 2023-11-08
76523SUPPL 2023-11-08
76522SUPPL 2023-11-08
942SUPPL2011-03-23
11233SUPPL2011-03-21
40805SUPPL2009-09-14
40804SUPPL2009-09-14
40803SUPPL2009-09-14
20128SUPPL2009-09-14
20127SUPPL2009-09-14
15028SUPPL2007-11-08
941SUPPL2007-03-06
15027SUPPL2007-01-08
940SUPPL2004-06-10