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FDA Approval Activities for this Drug…
Enalapril Maleate and Hydrochlorothiazide Tablets USP, 5 mg/12.5 mg and 10 mg/25 mg, Eon Labs Manufacturing, ANDA 76-116 9/19/01 Enalapril Maleate and Hydrochlorothiazide Tablets USP, 5 mg/12.5 mg and 10 mg/25 mg, Dr. Reddy's Limited ANDA 75-909 10/15/01 4/17/03 1/17/02 Enalapril Maleate and Hydrochlorothiazide Tablets USP, 5 mg/12.5 mg and 10 mg/25 mg, Taro Industries Ltd. ANDA 75-788 9/18/01 4/15/03 Enalapril Maleate and Hydrochlorothiazide Tablets USP, 5 mg/12.5 mg and 10 mg/25 mg, Taro ANDA 75-788 4/18/01 4/24/01 Enalapril Maleate and Hydrochlorothiazide Tablets USP, 5 mg/12.5 mg and 10 mg/25 mg, Ivax ANDA 75-736 3/25/03 Enalapril Maleate and Hydrochlorothiazide Tablets USP, 5 mg/12.5 mg and 10 mg/25 mg, Teva ANDA 75-727 9/18/01 4/14/03 Enalapril Maleate and Hydrochlorothiazide Tablets USP, 5 mg/12.5 mg and 10 mg/25 mg, Teva ANDA 75-727 6/8/01 6/26/01 Enalapril and Hydrochlorothiazide Tablets USP, 5 mg/12.5 mg and 10 mg/25 mg, Mylan ANDA 75-624 9/18/01 4/14/03 Enalapril and Hydrochlorothiazide Tablets USP, 5 mg/12.5 mg and 10 mg/25 mg, 2/22/2000 Mylan ANDA 75-624 2/22/00 2/24/00 Enalapril Maleate Tablets USP, 2.5 mg, 5 mg, 10 mg and 20 mg, Taro Pharmaceutical ANDA 75-657 1/23/01 3/5/01 Enalapril Maleate Tablets USP, 2.5 mg, 5 mg, 10 mg and 20 mg, Eon Labs Manufacturing, ANDA 75-621 8/22/00 11/7/00 Enalapril Maleate Tablets USP, 2.5 mg, 5 mg, 10 mg and 20 mg, 6/29/2000 Eon Labs Manufacturing, ANDA 75-621 6/29/00 11/7/00 Enalapril Maleate Tablets USP, 2.5 mg, 5 mg, 10 mg and 20 mg, Apothecon , A Bristol-Myers Squibb Co. ANDA 75-583 8/22/00 Enalapril Maleate Tablets USP, 2.5 mg, 5 mg, 10 mg and 20 mg, 3/29/2000 Apothecon , A Bristol-Myers Squibb Co. ANDA 75-583 3/29/00 3/31/00 Enalapril Maleate Tablets USP, 2.5 mg, 5 mg, 10 mg and 20 mg, Ranbaxy Ltd. ANDA 75-556 8/22/00 11/6/00 Enalapril Maleate Tablets USP, 2.5 mg, 5 mg, 10 mg and 20 mg, 4/17/2000 Ranbaxy Ltd. ANDA 75-556 4/17/00 4/24/00 Enalapril Maleate Tablets USP, 2.5 mg, 5 mg, 10 mg, & 20 mg, Chelsea , ANDA 75-501 8/22/00 11/6/00 Enalapril Maleate Tablets USP, 2.5 mg, 5 mg, 10 mg, & 20 mg, 5/19/2000 Chelsea , ANDA 75-501 5/19/00 5/22/00 Enalapril Maleate Tablets USP, 2.5 mg, 5 mg, 10 mg and 20 mg, LEK Pharmaceutical & Chemical Company d.d. ANDA 75-496 8/22/00 Enalapril Maleate Tablets USP, 2.5 mg, 5 mg, 10 mg and 20 mg, Wockhardt Americas ANDA 75-483 8/22/00 11/6/00 Enalapril Maleate Tablets USP, 2.5 mg, 5 mg, 10 mg and 20 mg, Zenith Goldline ANDA 75-482 8/22/00 11/6/00 Enalapril Maleate Tablets USP, 2.5 mg, 5 mg, 10 mg and 20 mg, 2/22/00 Zenith Goldline ANDA 75-482 2/22/00 2/24/00 Enalapril Maleate Tablets USP, 2.5 mg, 5 mg, 10 mg and 20 mg, Mylan ANDA 75-480 8/22/00 11/6/00 Enalapril Maleate Tablets USP, 2.5 mg, 5 mg, 10 mg and 20 mg, 2/18/2000 Mylan ANDA 75-480 2/18/00 2/24/00 Enalapril Maleate Tablets USP, 2.5 mg, 5 mg, 10 mg and 20 mg, Teva ANDA 75-479 8/22/00 11/6/00 Enalapril Maleate Tablets USP, 2.5 mg, 5 mg, 10 mg and 20 mg, 6/29/2000 Teva ANDA 75-479 4/12/00 4/17/00 Enalapril Maleate Tablets USP, 2.5 mg and 5 mg/10 mg and 20 mg., Par ANDA 75-472 8/22/00 11/6/00 Enalapril Maleate Tablets USP, 2.5 mg and 5 mg/10 mg and 20 mg., 3/28/00 Genpharm ANDA 75-472 6/29/00 11/6/00 Enalapril Maleate Tablets USP, 10 mg and 20 mg, LEK Pharmaceutical & Chemical Company d.d. ANDA 75-459 / 75-496 8/22/00 11/6/00 Enalapril Maleate Tablets USP, 2.5 mg and 5 mg/10 mg and 20 mg, Danbury Pharmacal, ANDA 75-370 / 75-369 8/22/00 10/30/00 Enalapril Maleate Tablets USP, 2.5 mg and 5 mg/10 mg and 20 mg., 3/28/00 Danbury Pharmacal, ANDA 75-370 / 75-369 3/28/00 4/4/00 Enalapril Maleate Tablets USP, 2.5 mg and 5 mg/10 mg and 20 mg., Jan. 29, 1999 Danbury Pharmacal, ANDA 75-370 / 75-369 1/29/99 2/5/99 2/5/99 Enalapril Maleate Tablets USP, 2.5 mg, 5 mg, 10 mg and 20 mg, 3/20/2000 ESI Lederle, ANDA 75-277 3/20/00 3/31/00 Enalapril Maleate Tablets USP, 2.5 mg, 5 mg, 10 mg and 20 mg, 3/29/1999 ESI Lederle, ANDA 75-277 3/29/99 3/30/99 Enalapril Maleate Tablets USP, 2.5 mg, 5 mg, 10 mg and 20 mg, Geneva ANDA 75-048 8/22/00 10/31/00 Enalapril Maleate Tablets USP, 2.5 mg, 5 mg, 10 mg and 20 mg, 3/5/1999 Geneva ANDA 75-048 3/5/99 8/18/00 Enalapril Maleate Tablets USP, 2.5 mg, 5 mg, 10 mg and 20 mg, Torpharm ANDA 75-178 3/23/01 3/30/01 Enalapril Maleate Tablets USP, 2.5 mg, 5 mg, 10 mg and 20 mg, 5/28/1999 Apotex ANDA 75-178 Lexxel (Enalapril Maleate/Felodipine ER) Tablets, Astra L.P. NDA 20-668/S-009 6/11/03 7/8/03 Lexxel (Enalapril Maleate/Lelodipine ER) Tablets, Astra L.P. NDA 20-668/S-003 Teczem (Enalapril Maleate/Diltiazem Maleate) Tablets, Prinzide (lisinopril/HCTZ) Tablets, Prinivil (lisinopril) Tablets, Vasotec (enalaprilat) IV, Vaseretic (enalapril maleate/HCTZ) Tablets, & Vasotec (enalapril maleate) Tablets Merck Research NDA 20-507/S001, 19-778/S029, 19-558/S036, 19-309/S022, 19-221/S025, & 18-998/S057 Vaseretic (Enalapril Maleate/Hydrochlorothiazide) Tablets & Vasotec (Enalaprilat) IV, 10/25 mg & 1.25 mg/mL, respectively, Merck NDA 19-221/S-027 & 19-309/S-025 10/30/02 11/19/02 Vaseretic (Enalapril Maleate/Hydrochlorothiazide) Tablets, 5/12.5 & 10/25 mg Merck NDA 19-221/S-024 10/13/98 6/25/99 Vasotec I.V. (Enalapril), (Enalapril Maleate) Tablets, & (Enalapril Maleate/Hydrochlorothiazide) Tablets, Merck and Company, NDA 19-309/S23 18-998/S058 & 19-221/S26 11/27/01 7/5/02 Vasotec (Enalapril Maleate) Tablets, 2.5, 5 10 and 20 mg Biovail Technologies Ltd. NDA 18-998/S063 8/30/02 9/11/02 Vasotec (Enalapril Maleate) Tablets, 2.5, 5 10 and 20 mg Merck and Company, NDA 18-998/S059 DILTIAZEM MALATE; ENALAPRIL MALEATE Tablet, Extended Release; 180MG HCL;5MG TECZEM BIOVAIL 075583 ENALAPRIL MALEATE Tablet; 10MG ENALAPRIL MALEATE APOTHECON 075583 ENALAPRIL MALEATE Tablet; 2.5MG ENALAPRIL MALEATE APOTHECON 075583 ENALAPRIL MALEATE Tablet; 20MG ENALAPRIL MALEATE APOTHECON 075583 ENALAPRIL MALEATE Tablet; 5MG ENALAPRIL MALEATE APOTHECON 018998 ENALAPRIL MALEATE Tablet; 10MG VASOTEC BIOVAIL 018998 ENALAPRIL MALEATE Tablet; 2.5MG VASOTEC BIOVAIL 018998 ENALAPRIL MALEATE Tablet; 20MG VASOTEC BIOVAIL 018998 ENALAPRIL MALEATE Tablet; 5MG VASOTEC BIOVAIL 075621 ENALAPRIL MALEATE Tablet; 10MG ENALAPRIL MALEATE Eon 075621 ENALAPRIL MALEATE Tablet; 2.5MG ENALAPRIL MALEATE Eon 075621 ENALAPRIL MALEATE Tablet; 20MG ENALAPRIL MALEATE Eon 075621 ENALAPRIL MALEATE Tablet; 5MG ENALAPRIL MALEATE Eon 075048 ENALAPRIL MALEATE Tablet; 10MG ENALAPRIL MALEATE Geneva 075048 ENALAPRIL MALEATE Tablet; 2.5MG ENALAPRIL MALEATE Geneva 075048 ENALAPRIL MALEATE Tablet; 20MG ENALAPRIL MALEATE Geneva 075048 ENALAPRIL MALEATE Tablet; 5MG ENALAPRIL MALEATE Geneva 075472 ENALAPRIL MALEATE Tablet; 10MG ENALAPRIL MALEATE Genpharm 075472 ENALAPRIL MALEATE Tablet; 2.5MG ENALAPRIL MALEATE Genpharm 075472 ENALAPRIL MALEATE Tablet; 20MG ENALAPRIL MALEATE Genpharm 075472 ENALAPRIL MALEATE Tablet; 5MG ENALAPRIL MALEATE Genpharm 075482 ENALAPRIL MALEATE Tablet; 10MG ENALAPRIL MALEATE Ivax 075482 ENALAPRIL MALEATE Tablet; 2.5MG ENALAPRIL MALEATE Ivax 075482 ENALAPRIL MALEATE Tablet; 20MG ENALAPRIL MALEATE Ivax 075482 ENALAPRIL MALEATE Tablet; 5MG ENALAPRIL MALEATE Ivax 075369 ENALAPRIL MALEATE Tablet; 10MG ENALAPRIL MALEATE KRKA DD NOVO MESTO 075370 ENALAPRIL MALEATE Tablet; 2.5MG ENALAPRIL MALEATE KRKA DD NOVO MESTO 075369 ENALAPRIL MALEATE Tablet; 20MG ENALAPRIL MALEATE KRKA DD NOVO MESTO 075370 ENALAPRIL MALEATE Tablet; 5MG ENALAPRIL MALEATE KRKA DD NOVO MESTO 075459 ENALAPRIL MALEATE Tablet; 10MG ENALAPRIL MALEATE LEK 075496 ENALAPRIL MALEATE Tablet; 2.5MG ENALAPRIL MALEATE LEK 075459 ENALAPRIL MALEATE Tablet; 20MG ENALAPRIL MALEATE LEK 075496 ENALAPRIL MALEATE Tablet; 5MG ENALAPRIL MALEATE LEK 075480 ENALAPRIL MALEATE Tablet; 10MG ENALAPRIL MALEATE Mylan 075480 ENALAPRIL MALEATE Tablet; 2.5MG ENALAPRIL MALEATE Mylan 075480 ENALAPRIL MALEATE Tablet; 20MG ENALAPRIL MALEATE Mylan 075480 ENALAPRIL MALEATE Tablet; 5MG ENALAPRIL MALEATE Mylan 075556 ENALAPRIL MALEATE Tablet; 10MG ENALAPRIL MALEATE Ranbaxy 075556 ENALAPRIL MALEATE Tablet; 2.5MG ENALAPRIL MALEATE Ranbaxy 075556 ENALAPRIL MALEATE Tablet; 20MG ENALAPRIL MALEATE Ranbaxy 075556 ENALAPRIL MALEATE Tablet; 5MG ENALAPRIL MALEATE Ranbaxy 075657 ENALAPRIL MALEATE Tablet; 10MG ENALAPRIL MALEATE Taro 075657 ENALAPRIL MALEATE Tablet; 2.5MG ENALAPRIL MALEATE Taro 075657 ENALAPRIL MALEATE Tablet; 20MG ENALAPRIL MALEATE Taro 075657 ENALAPRIL MALEATE Tablet; 5MG ENALAPRIL MALEATE Taro 075479 ENALAPRIL MALEATE Tablet; 10MG ENALAPRIL MALEATE Teva 075479 ENALAPRIL MALEATE Tablet; 2.5MG ENALAPRIL MALEATE Teva 075479 ENALAPRIL MALEATE Tablet; 20MG ENALAPRIL MALEATE Teva 075479 ENALAPRIL MALEATE Tablet; 5MG ENALAPRIL MALEATE Teva 075178 ENALAPRIL MALEATE Tablet; 10MG ENALAPRIL MALEATE Torpharm 075178 ENALAPRIL MALEATE Tablet; 2.5MG ENALAPRIL MALEATE Torpharm 075178 ENALAPRIL MALEATE Tablet; 20MG ENALAPRIL MALEATE Torpharm 075178 ENALAPRIL MALEATE Tablet; 5MG ENALAPRIL MALEATE Torpharm 075501 ENALAPRIL MALEATE Tablet; 10MG ENALAPRIL MALEATE Watson 075501 ENALAPRIL MALEATE Tablet; 2.5MG ENALAPRIL MALEATE Watson 075501 ENALAPRIL MALEATE Tablet; 20MG ENALAPRIL MALEATE Watson 075501 ENALAPRIL MALEATE Tablet; 5MG ENALAPRIL MALEATE Watson 075483 ENALAPRIL MALEATE Tablet; 10MG ENALAPRIL MALEATE Wockhardt 075483 ENALAPRIL MALEATE Tablet; 2.5MG ENALAPRIL MALEATE Wockhardt 075483 ENALAPRIL MALEATE Tablet; 20MG ENALAPRIL MALEATE Wockhardt 075483 ENALAPRIL MALEATE Tablet; 5MG ENALAPRIL MALEATE Wockhardt 020668 ENALAPRIL MALEATE; FELODIPINE Tablet, Extended Release; 5MG;2.5MG LEXXEL ASTRAZENECA 020668 ENALAPRIL MALEATE; FELODIPINE Tablet, Extended Release; 5MG;5MG LEXXEL ASTRAZENECA 019221 ENALAPRIL MALEATE; HYDROCHLOROTHIAZIDE Tablet; 10MG;25MG VASERETIC BIOVAIL 019221 ENALAPRIL MALEATE; HYDROCHLOROTHIAZIDE Tablet; 5MG;12.5MG VASERETIC BIOVAIL 075909 ENALAPRIL MALEATE; HYDROCHLOROTHIAZIDE Tablet; 10MG;25MG ENALAPRIL MALEATE AND HYDROCHLOROTHIAZIDE DR REDDYS LTD 075909 ENALAPRIL MALEATE; HYDROCHLOROTHIAZIDE Tablet; 5MG;12.5MG ENALAPRIL MALEATE AND HYDROCHLOROTHIAZIDE DR REDDYS LTD 076116 ENALAPRIL MALEATE; HYDROCHLOROTHIAZIDE Tablet; 10MG;25MG ENALAPRIL MALEATE AND HYDROCHLOROTHIAZIDE Eon 076116 ENALAPRIL MALEATE; HYDROCHLOROTHIAZIDE Tablet; 5MG;12.5MG ENALAPRIL MALEATE AND HYDROCHLOROTHIAZIDE Eon 075736 ENALAPRIL MALEATE; HYDROCHLOROTHIAZIDE Tablet; 10MG;25MG ENALAPRIL MALEATE AND HYDROCHLOROTHIAZIDE Ivax 075736 ENALAPRIL MALEATE; HYDROCHLOROTHIAZIDE Tablet; 5MG;12.5MG ENALAPRIL MALEATE AND HYDROCHLOROTHIAZIDE Ivax 075624 ENALAPRIL MALEATE; HYDROCHLOROTHIAZIDE Tablet; 10MG;25MG ENALAPRIL MALEATE AND HYDROCHLOROTHIAZIDE Mylan 075624 ENALAPRIL MALEATE; HYDROCHLOROTHIAZIDE Tablet; 5MG;12.5MG ENALAPRIL MALEATE AND HYDROCHLOROTHIAZIDE Mylan 075788 ENALAPRIL MALEATE; HYDROCHLOROTHIAZIDE Tablet; 10MG;25MG ENALAPRIL MALEATE AND HYDROCHLOROTHIAZIDE Taro INDS 075788 ENALAPRIL MALEATE; HYDROCHLOROTHIAZIDE Tablet; 5MG;12.5MG ENALAPRIL MALEATE AND HYDROCHLOROTHIAZIDE Taro INDS 075727 ENALAPRIL MALEATE; HYDROCHLOROTHIAZIDE Tablet; 10MG;25MG ENALAPRIL MALEATE AND HYDROCHLOROTHIAZIDE Teva 075727 ENALAPRIL MALEATE; HYDROCHLOROTHIAZIDE Tablet; 5MG;12.5MG ENALAPRIL MALEATE AND HYDROCHLOROTHIAZIDE Teva 075456 ENALAPRILAT Injection 1.25MG/ML ENALAPRILAT Abbott 075458 ENALAPRILAT Injection 1.25MG/ML ENALAPRILAT Abbott 075634 ENALAPRILAT Injection 1.25MG/ML ENALAPRILAT Bedford 019309 ENALAPRILAT Injection 1.25MG/ML VASOTEC BIOVAIL 075571 ENALAPRILAT Injection 1.25MG/ML ENALAPRILAT Faulding 075578 ENALAPRILAT Injection 1.25MG/ML ENALAPRILAT Gensia Sicor LEXXEL (enalapril maleate/felodipine ER) Tablets, AstraZeneca LP | Enalapril Maleate & Hydrochlorothiazide Tablets, Apotex, Approval | LEXXEL (enalapril maleate-felodipine ER) Tablets, AstraZeneca, Labeling Revision | LEXXEL (enalapril maleate-felodipine ER) Tablets, AstraZeneca, Labeling Revision | LEXXEL (enalapril maleate-felodipine ER) Tablets, AstraZeneca, Labeling Revision | Vasotec (enalapril maleate)Tablets, Biovail Tech, Labeling Revision | Vaseretic (enalapril maleate/hydrochlorothiazide) Tablets, Biovail Tech, Labeling Revision | Vaseretic (enalapril maleate and hydrochlorothiazide) Tablets, Biovail Laboratories International SRL, Labeling Revision | Vasotec (enalapril maleate) Tablets, Biovail Laboratories International SRL, Labeling Revision
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