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FDA Approval Activities for this Drug…
Lisinopril & Hydrochlorothiazide Tablets USP, 10 mg/12.5 mg, 20 mg/12.5 mg & 20 mg/25 mg, West-ward Pharmaceutical Corp. ANDA 76-265 7/8/02 Lisinopril & Hydrochlorothiazide Tablets USP, 10 mg/12.5 mg, 20 mg/12.5 mg & 20 mg/25 mg, Eon Labs, ANDA 76-262 7/1/02 Lisinopril & Hydrochlorothiazide Tablets USP, 10 mg/12.5 mg, 20 mg/12.5 mg & 20 mg/25 mg, Purepac Pharmaceutical Co. ANDA 76-230 7/1/02 Lisinopril & Hydrochlorothiazide Tablets USP, 10 mg/12.5 mg, 20 mg/12.5 mg & 20 mg/25 mg, Watson, ANDA 76-194 7/1/02 Lisinopril Tablets USP, 2.5, 5 & 10mg, Purepac Pharmaceutical Co. ANDA 76-180 7/1/02 Lisinopril Tablets USP, 2.5, 5 & 10mg, Purepac Pharmaceutical Co. ANDA 76-180 1/18/02 4/11/03 | Lisinopril Tablets USP, 20, 30, & 40 mg, Purepac Pharmaceutical Co. ANDA 76-164 7/1/02 | Lisinopril Tablets USP, 20, 30, & 40 mg, Purepac Pharmaceutical Co. ANDA 76-164 3/8/02 4/11/03 Lisinopril & Hydrochlorothiazide Tablets USP, 10 mg/12.5 mg, 20 mg/12.5 mg, 20 mg/25 mg, Mylan ANDA 76-113 7/1/02 Lisinopril & Hydrochlorothiazide Tablets USP, 10 mg/12.5 mg, 20 mg/12.5 mg, 20 mg/25 mg, Mylan ANDA 76-113 1/7/02 4/10/03 | Lisinopril Tablets USP, 2.5, 5, 10, 20, 30, & 40 mg, Torpharm ANDA 76-102 9/30/02 | Lisinopril Tablets USP, 2.5, 5, 10, 20, 30, & 40 mg, Mylan ANDA 76-071 7/1/02 | Lisinopril Tablets USP, 2.5 mg, 5 mg, 10 mg, 20 mg, 30 mg, & 40 mg, 2nd Mylan ANDA 76-071 2/8/02 4/10/03 | Lisinopril Tablets USP, 2.5 mg, 5 mg, 10 mg, 20 mg, 30 mg, & 40 mg, Mylan ANDA 76-071 9/10/01 4/16/03 | Lisinopril Tablets USP, 30 mg, West-ward Pharmaceutical Corp. ANDA 76-063/S2 & S3 6/27/03 | Lisinopril Tablets USP, 2.5, 5, 10, 20, 30 & 40 mg, West-ward Pharmaceutical Corp. ANDA 76-063 7/1/02 | Lisinopril Tablets USP, 2.5, 5, 10, 20, 30 & 40 mg, Watson, ANDA 76-059 7/1/02 | Lisinopril Tablets USP, 2.5, 5, 10, 20, 30 & 40 mg, Watson Labs ANDA 76-059 2/5/02 4/10/03 Lisinopril & Hydrochorothiazide Tablets USP, 10 mg/12.5 mg, 20mg/12.5 mg & 20 mg/25 mg, Ranbaxy ANDA 76-007 7/1/02 4/10/03 | Lisinopril Tablets USP, 10 mg/12.5 mg, 20mg/12.5 mg & 20 mg/25 mg, Ranbaxy Limited ANDA 76-007 1/4/02 | Lisinopril Tablets USP, 2.5, 5, 10, 20, 30 & 40 mg, LEK Pharmaceutical and Chemical Company ANDA 75-999 7/1/02 | Lisinopril Tablets USP, 2.5, 5, 10, 20, 30 & 40 mg, LEK Pharmaceutical and Chemical Company ANDA 75-999 12/19/01 4/16/03 | Lisinopril Tablets USP, 30 mg, Ranbaxy ANDA 75-994/S1 & S2 2/11/03 | Lisinopril Tablets USP, 2.5, 5, 10, 20, 30, & 40 mg, Eon Labs ANDA 75-994 7/1/02 | Lisinopril Tablets USP, 2.5 mg, 5 mg, 10 mg, 20 mg, 30 mg, & 40 mg, Eon Labs Manufacturing ANDA 75-994 5/24/01 6/5/01 | Lisinopril Tablets USP, 2.5, 5, 10, 20 & 40 mg, Ranbaxy Limited ANDA 75-944 7/1/02 | Lisinopril Tablets USP, 2.5, 5, 10, 20 & 40 mg, Ranbaxy Limited ANDA 75-944 10/9/01 4/16/03 | Lisinopril Tablets USP, 2.5, 5, 10, 20 & 40 mg, 2nd Ranbaxy Limited ANDA 75-944 2/13/02 4/10/03 Lisinopril & Hydrochlorothiazide Tablets USP, 10 mg/12.5 mg, 20 mg/12.5 mg and 20 mg/25 mg, Geneva Pharmaceutical Technology ANDA 75-926 7/1/02 Lisinopril and Hydrochlorothiazide Tablets USP, 10 mg/12.5 mg, 20 mg/12.5 mg and 20 mg/25 mg, 2nd Geneva ANDA 75-926 2/22/02 Lisinopril and Hydrochlorothiazide Tablets USP, 10 mg/12.5 mg,20 mg/12.5 mg and 20 mg/25 mg, Geneva ANDA 75-926 10/17/01 4/16/03 | Lisinopril Tablets USP, 2.5, 5, 10, 20, 30 & 40 mg, Geneva Pharmaceutical Technology Corp. ANDA 75-903 7/1/02 | Lisinopril Tablets USP, 2.5, 5, 1, 20, 30 & 40 mg, Geneva ANDA 75-903 8/14/01 Lisinopril & Hydrochlorothiazide Tablets USP, 10 mg/12.5 mg, 20 mg/12.5 mg & 20 mg/25 mg, Teva USA ANDA 75-869 7/1/02 | Lisinopril Tablets USP, 10 mg/12.5 mg, 20 mg/12.5 mg, 20 mg/25 mg, Teva USA ANDA 75-869 4/18/01 4/24/01 | Lisinopril Tablets USP, 2.5 mg, 5 mg, 10 mg, 20 mg, 30 mg, and 40 mg, Teva USA ANDA 75-783 7/1/02 | Lisinopril Tablets USP, 2.5 mg, 5 mg, 10 mg, 20 mg, 30 mg, and 40 mg, Teva USA ANDA 75-783 1/30/01 3/5/01 | Lisinopril Tablets USP, 2.5 mg, 5 mg, 10 mg, 20 mg, 30 mg, and 40 mg, 2nd Teva USA ANDA 75-783 1/24/02 4/10/03 Lisinopril & Hydrochlorothiazide Tablets, 10 mg/12.5 mg, 20 mg/12.5 mg & 20 mg/25 mg, Ivax ANDA 75-776 7/1/02 | Lisinopril Tablets USP, 2.5, 5, 10, 20, 30 & 40 mg, Ivax ANDA 75-752 7/1/02 | Lisinopril Tablets USP, 2.5, 5, 10, 20, 30 & 40 mg, Zenith Goldline ANDA 75-752 12/19/01 4/15/03 | Lisinopril Tablets USP, 2.5 mg, 5 mg, 10 mg, 20 mg, 30 mg, and 40 mg, Par ANDA 75-743 7/1/02 | Lisinopril Tablets USP, 2.5 mg, 5 mg, 10 mg, 20 mg, 30 mg, and 40 mg, Par ANDA 75-743 Prinzide (Lisinopril/Hydrochlorothiazide) Tablets, 10/12.5 mg, 20/12.5 mg and 20/25 mg Merck & Co., NDA 19-778/S-034 7/2/02 7/9/02 Prinzide (lisinopril/hydrochlorothiazide) 20/12.5 and 20/25 mg Tablets. Merck Research NDA 19-778/S-032 11/8/02 11/19/02 Prinzide (Lisinopril/Hydrochlorothiazide) Tablets, 20-12.5 & 20-25 mg Merck Research NDA 19-778/S-028 Zestoretic (lisinopril/hydrochlorothiazide) Tablets, 20/12.5, 20/25 and 10/12.5 mg, AstraZeneca LP NDA 19-888/S-035 4/17/03 Zestril (lisinopril) Tablet, 2.5, 5, 10, 20, 30 & 40 mg, AstraZeneca NDA 19-777/S-044/42 7/1/03 7/6/03 7/8/03 Zestril (lisinopril) Tablet, 2.5, 5, 10, 20, & 40 mg, Zeneca NDA 19-777/S-033 5/1/98 8//8/01 Zestril (lisinopril) Tablet, 2.5, 5, 10, 20, & 40 mg, Zeneca NDA 19-777/S-034 11/6/98 8//8/01 Zestril (lisinopril) Tablet, 2.5, 5, 10, 20, & 40 mg, Zeneca NDA 19-777/S-035 1/20/99 6/22/01 Zestril (lisinopril), Tablet/Oral, Zeneca NDA 19-777/S-037 2/7/00 2/14/00 Zestril Indications: This supplemental new drug application provides for changes in several sections of the package insert to incorporate statements concerning the use of high doses of lisinopril to reduce the risk of the combined outcomes of mortality and hospitalization in patients with congestive heart failure. These statements are based on the results of the "Assessment of Treatment with Lisinopril and Survival (ATLAS)" study. Zestril (lisinopril) Tablet,AstraZeneca Pharmaceuticals | Zestoretic (lisinopril/hctz) Tablets, AstraZeneca Pharma, Labeling Revision | Zestril (lisinopril) Tablets, AstraZeneca Pharma, Labeling Revision | Lisinopril Tablets, Lupin Limited, Approval | Prinivil (lisinopril) Tablets, Merck & Co., Labeling Revision | Prinzide (lisinopril/hydrochlorothiazide) Tablets, Merck & Co., Labeling Revision | Lisinopril Tablets, Aurobindo Pharma, Approval | Prinivil (lisinopril) Tablets, Merck & Co., Labeling Revision | Prinzide (lisinopril/hctz) Tablets, Merck & Co., Labeling Revision | Zestril (lisinopril) Tablets, AstraZeneca Pharma, Labeling Revision | Zestoretic (lisinopril/hctz) Tablets, AstraZeneca Pharma, Labeling Revision | Lisinopril & Hydrochlorothiazide Tablets, Lupin Ltd., Approval | Prinivil (lisinopril) Tablets, Merck & Co., Labeling Revision | Prinzide (lisinopril/hctz) Tablets, Merck & Co., Labeling Revision | Prinivil (lisinopril) Tablets, Merck & Co., Labeling Revision | Prinzide (lisinopril/hctz) Tablets, Merck & Co., Labeling Revision | Lisinopril Tablets, Wockhardt Inc., Approval | Lisinopril Tablets, West-ward Pharma, Labeling | Lisinopril Tablets, Teva Pharma, Labeling | Zestril (lisinopril) Tablets, AstraZeneca Pharma, Labeling Revision | Zestoretic (lisinopril/hctz) Tablets, AstraZeneca Pharma, Labeling Revision | Zestril (lisinopril) Tablets, AstraZeneca, Labeling Revision | Zestoretic (lisinopril/hctz) Tablets, AstraZeneca, Labeling Revision | Prinivil (lisinopril) Tablets, Merck Research Laboratories, Labeling Revision | Prinzide (lisinopril and hydrochlorothiazide) Tablets, Merck Research Laboratories, Labeling Revision | Zestoretic (hydrochlorothiazide and lisinopril) Tablets, AstraZeneca Pharmaceuticals LP, Labeling Revision | Zestril (lisinopril) Tablets, AstraZeneca Pharmaceuticals LP, Labeling Revision | Zestril (lisinopril) Tablets, AstraZeneca Pharmaceuticals, Labeling Revision | Zestoretic (lisinopril and hydrochlorothiazide) Tablets, AstraZeneca Pharmaceuticals, Labeling Revision | Zestril (lisinopril) Tablets, AstraZeneca Pharmaceuticals, Labeling Revision | Zestoretic (lisinopril and hydrochlorothiazide) Tablets, AstraZeneca, Labeling Revision | Zestoretic (lisinopril and hydrochlorothiazide) Tablets, AstraZeneca Pharmaceuticals, LP, Labeling Revision | Zestril (lisinopril) Tablets, AstraZeneca Pharmaceuticals LP, Labeling Revision | Prinzide (lisinopril-hydrochlorothiazide) tablets, Merck, Labeling Revision | Prinivil (lisinopril) Tablets, Merck Sharp & Dohme Corp., Labeling Revision | Prinzide (lisinopril and hydrochlorothiazide) Tablets, Merck Sharp & Dohme Corp., Labeling Revision
  
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