FDA.reportPublic FDA data

Application 202491

Type
ANDA
Sponsor
TEVA PHARMS USA

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001OLMESARTAN MEDOXOMIL, AMLODIPINE AND HYDROCHLOROTHIAZIDEAMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMILTABLET;ORALEQ 5MG BASE;12.5MG;20MGNoNo
002OLMESARTAN MEDOXOMIL, AMLODIPINE AND HYDROCHLOROTHIAZIDEAMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMILTABLET;ORALEQ 5MG BASE;12.5MG;40MGNoNo
003OLMESARTAN MEDOXOMIL, AMLODIPINE AND HYDROCHLOROTHIAZIDEAMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMILTABLET;ORALEQ 5MG BASE;25MG;40MGNoNo
004OLMESARTAN MEDOXOMIL, AMLODIPINE AND HYDROCHLOROTHIAZIDEAMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMILTABLET;ORALEQ 10MG BASE;12.5MG;40MGNoNo
005OLMESARTAN MEDOXOMIL, AMLODIPINE AND HYDROCHLOROTHIAZIDEAMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMILTABLET;ORALEQ 10MG BASE;25MG;40MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0093-5002Olmesartan Medoxomil, Amlodipine and HydrochlorothiazideOlmesartan Medoxomil, Amlodipine and HydrochlorothiazideTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-5002Olmesartan Medoxomil, Amlodipine and HydrochlorothiazideOlmesartan Medoxomil, Amlodipine and HydrochlorothiazideTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-5002Olmesartan Medoxomil, Amlodipine and HydrochlorothiazideOlmesartan Medoxomil, Amlodipine and HydrochlorothiazideTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-5002Olmesartan Medoxomil, Amlodipine and HydrochlorothiazideOlmesartan Medoxomil, Amlodipine and HydrochlorothiazideTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-5002Olmesartan Medoxomil, Amlodipine and HydrochlorothiazideOlmesartan Medoxomil, Amlodipine and HydrochlorothiazideTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-5002Olmesartan Medoxomil, Amlodipine and HydrochlorothiazideOlmesartan Medoxomil, Amlodipine and HydrochlorothiazideTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-5002Olmesartan Medoxomil, Amlodipine and HydrochlorothiazideOlmesartan Medoxomil, Amlodipine and HydrochlorothiazideTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-5002Olmesartan Medoxomil, Amlodipine and HydrochlorothiazideOlmesartan Medoxomil, Amlodipine and HydrochlorothiazideTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-5003Olmesartan Medoxomil, Amlodipine and HydrochlorothiazideOlmesartan Medoxomil, Amlodipine and HydrochlorothiazideTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-5003Olmesartan Medoxomil, Amlodipine and HydrochlorothiazideOlmesartan Medoxomil, Amlodipine and HydrochlorothiazideTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-5003Olmesartan Medoxomil, Amlodipine and HydrochlorothiazideOlmesartan Medoxomil, Amlodipine and HydrochlorothiazideTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-5003Olmesartan Medoxomil, Amlodipine and HydrochlorothiazideOlmesartan Medoxomil, Amlodipine and HydrochlorothiazideTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-5003Olmesartan Medoxomil, Amlodipine and HydrochlorothiazideOlmesartan Medoxomil, Amlodipine and HydrochlorothiazideTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-5003Olmesartan Medoxomil, Amlodipine and HydrochlorothiazideOlmesartan Medoxomil, Amlodipine and HydrochlorothiazideTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-5003Olmesartan Medoxomil, Amlodipine and HydrochlorothiazideOlmesartan Medoxomil, Amlodipine and HydrochlorothiazideTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-5003Olmesartan Medoxomil, Amlodipine and HydrochlorothiazideOlmesartan Medoxomil, Amlodipine and HydrochlorothiazideTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-5004Olmesartan Medoxomil, Amlodipine and HydrochlorothiazideOlmesartan Medoxomil, Amlodipine and HydrochlorothiazideTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-5004Olmesartan Medoxomil, Amlodipine and HydrochlorothiazideOlmesartan Medoxomil, Amlodipine and HydrochlorothiazideTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-5004Olmesartan Medoxomil, Amlodipine and HydrochlorothiazideOlmesartan Medoxomil, Amlodipine and HydrochlorothiazideTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-5004Olmesartan Medoxomil, Amlodipine and HydrochlorothiazideOlmesartan Medoxomil, Amlodipine and HydrochlorothiazideTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-5004Olmesartan Medoxomil, Amlodipine and HydrochlorothiazideOlmesartan Medoxomil, Amlodipine and HydrochlorothiazideTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-5004Olmesartan Medoxomil, Amlodipine and HydrochlorothiazideOlmesartan Medoxomil, Amlodipine and HydrochlorothiazideTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-5004Olmesartan Medoxomil, Amlodipine and HydrochlorothiazideOlmesartan Medoxomil, Amlodipine and HydrochlorothiazideTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-5004Olmesartan Medoxomil, Amlodipine and HydrochlorothiazideOlmesartan Medoxomil, Amlodipine and HydrochlorothiazideTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-5005Olmesartan Medoxomil, Amlodipine and HydrochlorothiazideOlmesartan Medoxomil, Amlodipine and HydrochlorothiazideTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-5005Olmesartan Medoxomil, Amlodipine and HydrochlorothiazideOlmesartan Medoxomil, Amlodipine and HydrochlorothiazideTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-5005Olmesartan Medoxomil, Amlodipine and HydrochlorothiazideOlmesartan Medoxomil, Amlodipine and HydrochlorothiazideTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-5005Olmesartan Medoxomil, Amlodipine and HydrochlorothiazideOlmesartan Medoxomil, Amlodipine and HydrochlorothiazideTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-5005Olmesartan Medoxomil, Amlodipine and HydrochlorothiazideOlmesartan Medoxomil, Amlodipine and HydrochlorothiazideTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-5005Olmesartan Medoxomil, Amlodipine and HydrochlorothiazideOlmesartan Medoxomil, Amlodipine and HydrochlorothiazideTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-5005Olmesartan Medoxomil, Amlodipine and HydrochlorothiazideOlmesartan Medoxomil, Amlodipine and HydrochlorothiazideTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-5005Olmesartan Medoxomil, Amlodipine and HydrochlorothiazideOlmesartan Medoxomil, Amlodipine and HydrochlorothiazideTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-5006Olmesartan Medoxomil, Amlodipine and HydrochlorothiazideOlmesartan Medoxomil, Amlodipine and HydrochlorothiazideTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-5006Olmesartan Medoxomil, Amlodipine and HydrochlorothiazideOlmesartan Medoxomil, Amlodipine and HydrochlorothiazideTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-5006Olmesartan Medoxomil, Amlodipine and HydrochlorothiazideOlmesartan Medoxomil, Amlodipine and HydrochlorothiazideTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-5006Olmesartan Medoxomil, Amlodipine and HydrochlorothiazideOlmesartan Medoxomil, Amlodipine and HydrochlorothiazideTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-5006Olmesartan Medoxomil, Amlodipine and HydrochlorothiazideOlmesartan Medoxomil, Amlodipine and HydrochlorothiazideTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-5006Olmesartan Medoxomil, Amlodipine and HydrochlorothiazideOlmesartan Medoxomil, Amlodipine and HydrochlorothiazideTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-5006Olmesartan Medoxomil, Amlodipine and HydrochlorothiazideOlmesartan Medoxomil, Amlodipine and HydrochlorothiazideTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-5006Olmesartan Medoxomil, Amlodipine and HydrochlorothiazideOlmesartan Medoxomil, Amlodipine and HydrochlorothiazideTeva Pharmaceuticals USA, Inc.ANDACurrent