Content specific to this active ingredient… Drug Information Prescribing and patient information from leading authorities Drug Master Files Type 2 master files on file at the FDA Safety Information For prescription drugs containing this active ingredient Exclusivity Patent and market exclusivity data Federal Register FR search results for this API FDA Approved Labelling Information found in this drug's package inserts Research Links Chemical identification and research citations Title 21 Code of Federal Regulations FDA regulations for this API

FDA Approval Activities for this Drug… Atacand HCT (candesartan cilexetil - hydrochlorothiazide) Tablets, 16-12.5 and 32-12.5 mg, AstraZeneca LP NDA 21-093 9/5/00 9/11/00 9/11/00 7/30/01 | Atacand (candesartan cilexetil), Tablets, 4, 8, 16, and 32 mg, AstraZeneca LP NDA 20-838/S019 4/23/03 | Atacand (candesartan cilexetil), Tablets, 4, 8, 16, and 32 mg, AstraZeneca LP NDA 20-838/S017 1/22/03 1/27/03 | Atacand (candesartan cilexetil), Tablets, 4, 8, 16, and 32 mg AstraZeneca LP NDA 20-838/S015 9/13/02 9/20/02 9/17/02 2/4/03 | Atacand (candesartan cilexetil), Tablets, 4, 8, 16, and 32 mg AstraZeneca LP NDA 20-838/S008 6/14/00 6/6/01 | Atacand (candesartan cilexetil) Tablets, 4, 8, 16, and 32 mg Astra Merck NDA 20-838 6/4/98 6/8/98 6/8/98 4/11/02 | Atacand Indication: for the treatment of hypertension. It may be used alone or in combination with other antihypertensive agents. | Atacand (candesartan cilexetil) Tablets, AstraZeneca, Labeling Revision | | Atacand (candesartan cilexetil) Tablets, AstraZeneca, Labeling Revision | Atacand (candesartan cilexetil) Tablets, AstraZeneca, New or Modified Indication | Atacand (candesartan cilexetil) Tablets, AstraZeneca, New or Modified Indication | Atacand HCT (candesartan cilexetil and hydrochlorothiazide) Tablets, AstraZeneca, Labeling Revision | Atacand HCT (candesartan cilexetil) Tablets, AstraZeneca, Labeling Revision | ATACAND HCT (candesartan cilexetil and hydrochlorothiazide) Tablets, AstraZeneca LP, Formulation Revision | Atacand (candesartan cilexetil) Tablets, AstraZeneca, Efficacy Supplement with Clinical Data to Support | Atacand HCT (candesartan cilexitil and hydrochlorothiazide) Tablets, AstraZeneca, Labeling Revision | Atacand HCT (candesartan and cilexetil hydrochlorothiazide) Tablets, AstraZeneca, Labeling Revision | Atacand (candesartan cilexetil) Tablets, AstraZeneca LP, Labeling Revision | Candesartan Cilexetil and Hydrochlorothiazide Tablets, Matrix Laboratories Ltd., Tentative Approval | Candesartan Cilexetil, candesartan cilexetil, Tablet; Oral, Matrix Labs Ltd, Tentative Approval ^ FDA's latest approval appears at the bottom of this list. ^                                                                       A | B | C | D | E | F | G | H | I | J | K | L | M | N | O | P | Q | R | S | T | U-Z Health Topics | For Industry | DMF Index | Pharma Job Search | Pharma Company News | Best Phone © 2012 Betterchem.com