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FDA Approval Activities for this Drug…
Hydrochlorothiazide Capsules, 12.5 mg, Vintage ANDA 75-907 9/17/02 Hydrochlorothiazide Capsules, 12.5 mg, Mylan ANDA 75-640 1/28/00 2/4/00 Hydrochlorothiazide Tablets, 25 7 50 mg, Vintage ANDA 40-412 Micardis HCT (telmisartan / hydrochlorothiazide) Tablets, Boehringer Ingelheim | Fosinopril Sodium & Hydrochlorothiazide Tablets, Andrx Pharma, Approval | Aldoril (methyldopa/hydrochlorothiazide) Tablets, Merck & Company, Labeling Revision | Avalide (irbesartan/hydrochlorothiazide) Tablets, Sanofi-Synthelabo, Formulation Revision | Quinapril hydrochloride & Hydrochlorothiazide Tablets, Mylan Pharma, Approval | Zestoretic (lisinopril/hctz) Tablets, AstraZeneca Pharma, Labeling Revision | Diovan HCT (valsartan/ hydrochlorothiazide) Tablets, Novartis Pharma, Labeling Revision | Diovan HCT (valsartan/ hydrochlorothiazide) Tablets, Novartis Pharma, Labeling Revision | Teveten HCT (eprosartan mesylate/hydrochlorothiazide) tablets, Kos Life Sciences, Control Supplement | Hydrochlorothiazide Capsules, Ivax Pharma, Approval | Fosinopril Sodium & Hydrochlorothiazide Tablets, Watson Labs, Approval | MICARDIS HCT (telmisartan/hydrochlorothiazide) Tablets, Boehringer Ingelheim Pharma, Labeling Revision | Benazepril Hydrochloride & Hydrochlorothiazide Tablets, Ranbaxy, Approval | Fosinopril Sodium and Hydrochlorothiazide Tablets, Sandoz, Approval | Prinzide (lisinopril/hydrochlorothiazide) Tablets, Merck & Co., Labeling Revision | HYZAAR (losartan/potassium hydrochlorothiazide) Tablets, Merck Research, New Dosage Regimen | Avalide (irbesartan/hydrochlorothiazide) Tablets, Sanofi-Aventis, Labeling Revision | HYZAAR (losartan potassium hydrochlorothiazide) Tablets, Merck Research, Labeling Revision | Avalide (irbesartan-hydrochlorothiazide) Tablets, Sanofi-Aventis, Labeling | Avapro (irbesartan) Tablets, Sanofi-Aventis, Labeling Revision | Losartan Potassium and Hydrochlorothiazide Tablets, Teva Pharma, Tentative Approval | Prinzide (lisinopril/hctz) Tablets, Merck & Co., Labeling Revision | Zestoretic (lisinopril/hctz) Tablets, AstraZeneca Pharma, Labeling Revision | Fosinopril Sodium & Hydrochlorothiazide Tablets, Teva Pharma, Approval | Losartan Potassium & Hydrochlorothiazide Tablets, Roxane Labs, Tentative Approval | Fosinopril Sodium & Hydrochlorothiazide Tablets, Genpharm, Approval | Losartan Potassium & Hydrochlorothiazide Tablets, Roxane Labs, Tentative Approval | Hyzaar Tablet, Merck, Labeling Revision | Lopressor HCT (metoprolol tartrate and hydrochlorothiazide) Tablets, Novartis Pharma, Labeling Revision | Lisinopril & Hydrochlorothiazide Tablets, Lupin Ltd., Approval | Hyzaar (losartan potassium/hydrochlorothiazide) Tablets, Merck Research Labs, Labeling Revision | Inderide (propranolol hydrochloride and hydrochlorothiazide) Tablets, Wyeth Pharma, Labeling Revision | Lotensin HCT (benazepril HCl/hctz) Tablets, Novartis Pharma, Labeling Revision | Prinzide (lisinopril/hctz) Tablets, Merck & Co., Labeling Revision | Hydrochlorothiazide Tablets, Excellium Pharma, Approval | Hydrochlorothiazide Tablets, Caraco Pharma, Approval | Dyazide (hydrochlorothiazide/triamterene) Capsules, GlaxoSmithKline, Labeling Revision | Quinapril Hydrochloride and Hydrochlorothiazide Tablets, Aurobindo Pharma, Tentative Approval | Zestoretic (lisinopril/hctz) Tablets, AstraZeneca Pharma, Labeling Revision | Hydrochlorothiazide Tablets, Aurobindo Pharma, Approval | Hydrochlorothiazide Tablets, Ohm Labs, Approval | Hydrochlorothiazide Tablets, Cadista Pharma, Approval | Diovan HCT (valsartan/hydrochlorothiazide) Tablets, Novartis Pharma, Labeling Revision | Hydrochlorothiazide Tablets, Actavis Elizabeth, Package Change | Triamterene and Hydrochlorothiazide Capsules, Mylan Pharma, Control Suppl. | Hydrochlorothiazide Capsules, Aurobindo Pharma, Approval | Ziac (bisoprolol fumarate and hydrochlorothiazide) Tablets, Duramed Pharma, Labeling Revision | Hydrochlorothiazide Tablets, Apotex, Approval | Zestoretic (lisinopril/hctz) Tablets, AstraZeneca, Labeling Revision | Vaseretic (enalapril maleate/hydrochlorothiazide) Tablets, Biovail Tech, Labeling Revision | Losartan Potassium and Hydrochlorothiazide Tablets, Lek Pharma, Tentative Approval | Benicar HCT (olmesartan medoxomil/hydrochlorothiazide) Tablets, Daichi Sankyo, Labeling Revision | Avalide (irbesartan/hydrochlorothiazide) Tablets, Sanofi-Aventis, New or Modified Indication | Hydrochlorothiazide Capsules, West-ward Pharma, Approval | Tekturna HCT (aliskiren/hydrochlorothiazide) Tablets, Novartis Pharma, Approval | Hydrochlorothiazide Capsules, Cadista Pharma, Approval | Hydrochlorothiazide Tablets, Apotex Corp., Facility Addition | Losartan Potassium and Hydrochlorothiazide Tablets, Zydus Pharma, Tentative Approval | ATACAND HCT (candesartan cilexetil and hydrochlorothiazide) Tablets, AstraZeneca LP, Formulation Revision | Hydrochlorothiazide Capsules, Apotex Corp., Approval | Lotensin (benazepril hydrochloride) Tablets, Novartis Pharmaceuticals Corp., Labeling Revision | Lotensin HCT (benazepril hydrochloride and hydrochlorothiazide) Tablets, Novartis Pharmaceuticals Corp., Labeling Revision | Hydrochlorothiazide Tablets, Caraco Pharmaceutical Laboratories, Ltd., Approval | Valsartan and Hydrochlorothiazide Tablets, Mylan Pharmaceuticals Inc., Tentative Approval | Irbesartan and Hydrochlorothiazide Tablets, Mylan Pharmaceuticals, Inc., Tentative Approval | Tekturna HCT (aliskiren hemifumarate/hydrochlorothiazide) Tablets, Novartis Pharma, Labeling Revision | Lopressor HCT (hydrochlorothiazide and metoprolol tartrate) Tablets, Novartis Pharmaceuticals Corp., Labeling Revision | Hydrochlorothiazide Tablets, Unichem Laboratories Ltd., Approval | Moexipril Hydrochloride and Hydrochlorothiazide Tablets, Paddock Laboratories, Inc., Approval | Vaseretic (enalapril maleate and hydrochlorothiazide) Tablets, Biovail Laboratories International SRL, Labeling Revision | Olmesartan Medoxomil and Hydrochlorothiazide Tablets, Mylan Pharmaceuticals Inc., Tentative Approval | Prinzide (lisinopril and hydrochlorothiazide) Tablets, Merck Research Laboratories, Labeling Revision | Capozide (captopril and hydrochlorothiazide) Tablets, Bristol-Myers Squibb, Labeling Revision | Quinapril Hydrochloride and Hydrochlorothiazide Tablets, Ranbaxy Laboratories Ltd., Approval | Exforge HCT (amlodipine, valsartan and hydrochlorothiazide) Tablets, Novartis Pharmaceuticals Corp., Approval | Losartan Potassium and Hydrochlorothiazide Tablets, Roxane Laboratories, Inc., Tentative Approval | Zestoretic (hydrochlorothiazide and lisinopril) Tablets, AstraZeneca Pharmaceuticals LP, Labeling Revision | Hyzaar (hydrochlorothiazide, losartan and potassium) Tablets, Merck & Co., Inc., Labeling Revision | Tekturna HCT (aliskiren hemifumarate and hydrochlorothiazide) Tablets, Novartis Pharmaceuticals Corp., New or Modified Indication | Accuretic (hydrochlorothiazide and quinapril hydrochloride) Tablets, Pfizer Inc., Labeling Revision | Losartan Potassium and Hydrochlorothiazide Tablets, Apotex Inc., Tentative Approval | Lotensin (benazepril/hydrochlorothiazide) Tablets, Novartis, Labeling Revision | Lotensin HCT (benazepril/hydrochlorothiazide) Tablets, Novartis, Labeling Revision | Ziac (bisoprolol fumarate and hydrochlorothiazide) Tablets, Duramed Pharmaceuticals, Inc., Labeling Revision | Uniretic (moexipril hydrochloride and hydrochlorothiazide) Tablets, Schwarz Pharma, Labeling Revision | Hydrochlorothiazide Capsules, Unichem Laboratories Ltd., Approval | Dyazide (hydrochlorothiazide and triamterene) Capsules, GlaxoSmithKline, Labeling Revision | Inderide-40/25 (hydrochlorothiazide and propranolol hydrochloride) Tablets, Akrimax Pharmaceuticals, LLC, Labeling Revision | Inderide-80/25 (hydrochlorothiazide and propranolol hydrochloride) Tablets, Akrimax Pharmaceuticals, LLC, Labeling Revision | Moexipril Hydrochloride and Hydrochlorothiazide Tablets, Glenmark Generics Inc., Approval | Losartan Potassium and Hydrochlorothiazide Tablets, Mylan Pharmaceuticals, Inc., Approval | Losartan Potassium and Hydrochlorothiazide Tablets, Roxane Laboratories, Inc., Approval | Losartan Potassium and Hydrochlorothiazide Tablets, Teva Pharmaceuticals USA, Approval | Diovan HCT (valsartan and hydrochlorothiazide) Tablets, Novartis Pharmaceuticals Corp., Labeling Revision | Losartan Potassium and Hydrochlorothiazide Tablets, Lupin Limited, Tentative Approval and Approval | Tekturna HCT (aliskiren hemifumarate and hydrochlorothiazide) Tablets, Novartis Pharmaceuticals Corporation, Labeling Revision | Bisoprolol Fumarate and Hydrochlorothiazide Tablets, Unichem Laboratories Ltd., Approval | Tribenzor (olmesartan medoxomil, amlodipine and hydrochlorothiazide) Tablets, Daiichi Sankyo, Inc., Approval | Losartan Potassium and Hydrochlorothiazide Tablets, Apotex, Inc., Approval | Losartan Potassium and Hydrochlorothiazide Tablets, Sandoz, Inc., Approval | Valsartan and Hydrochlorothiazide Tablets, Mylan Pharmaceuticals Inc., Tentative Approval | Avalide (irbesartan and hydrochlorothiazide) Tablets, Bristol-Myers Squibb Company, Labeling Revision | Hyzaar (losartan potassium and hydrochlorothiazide) Tablets, Merck and Company, Labeling Revision | Fosinopril Sodium and Hydrochlorothiazide Tablets, Actavis Totowa LLC, Approval | Losartan Potassium and Hydrochlorothiazide Tablets, Zydus Pharmaceuticals, Approval | Losartan Potassium and Hydrochlorothiazide Tablets, Roxane Laboratories, Inc., Approval | Losartan Potassium and Hydrochlorothiazide Tablets, Apotex, Inc., Approval | Hydrochlorothiazide Capsules, Alembic Ltd., Approval | Losartan Potassium and Hydrochlorothiazide Tablets, Watson Laboratories, Inc, Approval | Irbesartan and Hydrochlorothiazide Tablets, Zydus Pharmaceuticals USA Inc., Tentative Approval | Tekturna HCT (aliskiren hemifumarate and hydrochlorothiazide) Tablets, Novartis Pharmaceuticals Corp., Labeling Revision | Dutoprol (metoprolol succinate and hydrochlorothiazide) Extended-Release Tablets, AstraZeneca L.P., Labeling Revision | Dyazide (hydrochlorothiazide and triamterene) Capsules, GlaxoSmithKlein, Labeling Revision | Lotensin HCT (benazapril hydrochloride and hydorchlorothiazide) Tablets, Novartis Pharmaceuticals, Labeling Revision | Microzide (hydrochlorothiazide) Capsules, Watson Pharmaceuticals, Labeling Revision | Vaseretic (enalapril maleate and hydrochlorothiazide) Tablets, Biovail Laboratories, Labeling Revision | Zestoretic (lisinopril and hydrochlorothiazide) Tablets, AstraZeneca, Labeling Revision | Irbesartan and Hydrochlorothiazide Tablets, Roxane Laboratories, Inc., Tentative Approval | Accuretic (hydrochlorothiazide and quinapril hydrochloride) Tablets, Pfizer, Inc., Labeling Revision | Maxzide (hydrochlorothiazide and triamterene) Tablets, Mylan Pharmaceuticals Inc., Labeling Revision | Inderide (propranolol hydrochloride and hydrochlorothiazide) Tablets, Akrimax Pharmaceuticals, Labeling Revision | Quinapril Hydrochloride and Hydrochlorothiazide Tablets, Invagen Pharmaceuticals, Inc., Approval | Olmesartan Medoxomil and Hydrochlorothiazide Tablets, Mylan Pharmaceuticals Inc., Tentative Approval | Micardis HCT (telmisartan and hydrochlorothiazide) Tablets, Boerhinger Ingelheim Pharmaceuticals, Inc., Labeling Revision | Ziac (bisoprolol fumarate and hydrochlorothiazide) Tablets, Teva Women’s Health, Inc., Labeling Revision | Aldactazide (spironolactone and hydrochlorothiazide) Tablets, Pfizer, Inc., Labeling Revision | Teveten HCT (eprosartan mesylate and hydrochlorothiazide) Tablets, Abbott Laboratories, Labeling Revision | Uniretic (moexipril hydrochloride and hydrochlorothiazide) Tablets, UCB, Inc., Labeling Revision | Avalide (hydrochlorothiazide and irbesartan) Tablets, Sanofi-Aventis, Labeling Revision | Diovan HCT (hydrochlorothiazide and valsartan) Tablets, Novartis Pharmaceuticals Corp., Labeling Revision | Exforge HCT (amlodipine besylate, hydrochlorothiazide and valsartan) Tablets, Novartis Pharmaceuticals Corp., Labeling Revision | Atacand HCT (candesartan and cilexetil hydrochlorothiazide) Tablets, AstraZeneca, Labeling Revision | Lotensin HCT (benazepril hydrochloride and hydrochlorothiazide) Tablets, Novartis Pharmaceuticals Corp., Labeling Revision | Tekturna HCT (aliskiren hemifumarate and hydrochlorothiazide) Tablets, Novartis Pharmaceuticals Corp., Labeling Revision | Tribenzor (olmesartan medoxomil, amlodipine besylate and hydrochlorothiazide) Tablets, Daiichi Sankyo, Inc., Labeling Revision | Zestoretic (lisinopril and hydrochlorothiazide) Tablets, AstraZeneca Pharmaceuticals, LP, Labeling Revision | Candesartan Cilexetil and Hydrochlorothiazide Tablets, Matrix Laboratories Ltd., Tentative Approval | Hyzaar (losartan potassium and hydrochlorothiazide) Tablets, Merck, Labeling Revision | Hydrochlorothiazide Tablets, Mylan Pharmaceuticals Inc., Labeling Revision | Prinzide (lisinopril-hydrochlorothiazide) tablets, Merck, Labeling Revision | Telmisartan and Hydrochlorothiazide Tablets, Watson Laboratories, Inc., Tentative Approval | Amturnide (amlodipine besylate, aliskiren hemifumarate and hydrochlorothiazide) Tablets, Novartis Pharmaceuticals Corp., Labeling Revision | Tekurna (aliskiren hemifumarate) Tablets, Novartis Pharmaceuticals Corp., Labeling Revision | Tekturna HCT (aliskiren hemifumarate and hydrochlorothiazide) Tablets, Novartis Pharmaceuticals Corp., Labeling Revision | Accuretic (hydrochlorothiazide and quinapril hydrochloride) Tablets, Pfizer Inc., Labeling Revision | Amturnide (aliskiren hemifumarate, amlodipine besylate and hydrochlorothiazide) Tablets, Novartis Pharmaceuticals Corp., Labeling Revision | Tribenzor (olmesartan medoxomil, amlodipine besylate and hydrochlorothiazide) Tablets, Daiichi Sankyo, Inc., Labeling Revision | Exforge HCT (amlodipine, valsartan and hydrochlorothiazide) Tablets, Novartis Pharmaceuticals Corp., Labeling Revision | Hyzaar (losartan potassium and hydrochlorothiazide) Tablets, Merck Sharp & Dohme Corp., Labeling Revision |Prinzide (lisinopril and hydrochlorothiazide) Tablets, Merck Sharp & Dohme Corp., Labeling Revision | Exforge HCT (amlodipine besylate, valsartan and hydrochlorothiazide) Tablets, Novartis Pharmaceuticals Corp., Labeling Revision | Diovan HCT (hydrochlorothiazide and valsartan) Tablets, Novartis Pharmaceuticals Corp., Labeling Revision | Dutoprol, hydrochlorothiazide; metoprolol succinate, Tablet, Extended Release; Oral, Astrazeneca, Labeling Revision
  
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