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… Cardizem CD ( Diltiazem Hydrochloride) Capsules, 180, 240, 300 & 360 mg, Biovail Incorporated NDA 20-062/S027 8/24/99 7/3/01 | Cardizem Tablets, Cardizem SR and Cardizem CD (diltiazem hydrochloride) Capsules, Biovail Incorporated NDA 18-602/S-056, 19-471/S-029, 20-062/S025 3/21/03 | Cardizem LA (diltiazem hydrochloride) Extended-Release Tablets, 120, 180, 240, 300, 360, and 420 mg, Biovail Incorporated NDA 21-392 Cartia XT (Diltiazem Hydrochloride USP) Extended-release Capsules, 120 mg, 180 mg, 240 mg, 300 mg, Andrx ANDA 74-752 Diltiazem Hydrochloride Extended-release Capsules, Biovail Incorporated NDA 20-939 1/28/00 2/3/00 2/3/00 2/19/02 | Diltiazem Indication: NDA 20-939: Hypertension Dosage | Diltiazem Hydrochloride Extended-release Capsules USP, 120 mg, 180 mg, 240 mg, & 300 mg., Keller and Heckman ANDA 75-116 12/23/99 1/4/99 | Diltiazem Hydrochloride Extended-release Capsules USP, 120 mg, 180 mg, & 240 mg, Mylan ANDA 75-124 3/18/98 3/22/99 | Diltiazem Hydrochloride Extended-release Capsules USP, 240 mg, Torpharm ANDA 74-943 8/6/98 8/7/98 8/6/03 | Diltiazem Hydrochloride Extended-release Capsules USP(Once-a-Day Dosage), 120 mg, 180 mg, 240 mg and 300 mg, Purepac Pharmaceutical ANDA 74-984 12/20/99 12/27/99 | Diltiazem Hydrochloride Extended-release Capsules USP, 60 mg, 90 mg, & 120 mg Biovail Corp. Intl. ANDA 74-845 9/15/99 9/24/99 8/22/01 | Diltiazem Hydrochloride Extended-release Capsules USP, 120 mg, 180 mg, 240 mg, and 300 mg. Andrx ANDA 74-752 7/9/98 8/16/00 | | 8/16/00 8/16/00 | Diltiazem Hydrochloride Injection, 100 mg/mL, Abbott ANDA 75-853 12/17/02 | Diltiazem Hydrochloride Injection, 5 mg/mL, International Medication Systems, Ltd ANDA 75-749 11/21/01 4/15/03 | Diltiazem Hydrochloride Injection, 5 mg/mL, Apotex Corp. ANDA 75-375 9/30/99 10/1/99 | Diltiazem Hydrochloride Injection, 5 mg/mL Abbott NDA 74-941 8/15/99 4/23/03 | Diltiazem Hydrochloride Injection, 5 mg/mL, Taylor ANDA 75-086 4/9/98 8/24/01 | Diltiazem Hydrochloride Injection, 5 mg/mL, [packed in 5 mL (25 mg), & 10 mL (50 mg) vials]. Meridian Medical Technologies, ANDA 75-106 4/29/99 5/4/99 | Diltiazem Hydrochloride Injection, 5 mg/mL, 5 mL Syringes, Abbott ANDA 75-004 2/16/00 2/24/00 | Diltiazem Hydrochloride Injection, 5 mg/mL, (25 mL Vial), Gensia Sicor ANDA 74-894/S1 Taztia XT (Diltiazem Hydrochloride Extended-release Capsules USP, 120, 180, 240, 300, and 360 mg, Andrx ANDA 75-401 4/10/03 | Taztia XT (Diltiazem Hydrochloride Extended-release Capsules USP,120, 180, 240, 300, and 360 mg, Andrx ANDA 75-401 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 Tiazac/Diltiazem Hydrochloride) Capsules Biovail NDA 20-401 | /S019 3/24/00 6/6/01 | Tiazac/Diltiazem Hydrochloride Capsules, 420 mg Biovail NDA 20-401 | /S013 10/16/98 12/4/01 | Tiazac/Diltiazem Hydrochloride Biovail NDA 20-401 | /S007 DILTIAZEM HYDROCHLORIDE Capsule, Extended Release; 120MG DILTIAZEM HCL Andrx 074852 AB2 DILTIAZEM HYDROCHLORIDE Capsule, Extended Release; 180MG DILTIAZEM HCL Andrx 074852 AB2 DILTIAZEM HYDROCHLORIDE Capsule, Extended Release; 240MG DILTIAZEM HCL Andrx 075401 AB4 DILTIAZEM HYDROCHLORIDE Capsule, Extended Release; 120MG TAZTIA XT Andrx 074752 AB3 DILTIAZEM HYDROCHLORIDE Capsule, Extended Release; 120MG CARTIA XT Andrx | 075401 AB4 DILTIAZEM HYDROCHLORIDE Capsule, Extended Release; 180MG TAZTIA XT Andrx | 074752 AB3 DILTIAZEM HYDROCHLORIDE Capsule, Extended Release; 180MG CARTIA XT Andrx | 075401 AB4 DILTIAZEM HYDROCHLORIDE Capsule, Extended Release; 240MG TAZTIA XT Andrx | 074752 AB3 DILTIAZEM HYDROCHLORIDE Capsule, Extended Release; 240MG CARTIA XT Andrx | 074752 AB3 DILTIAZEM HYDROCHLORIDE Capsule, Extended Release; 300MG CARTIA XT Andrx | 075401 AB4 DILTIAZEM HYDROCHLORIDE Capsule, Extended Release; 300MG TAZTIA XT Andrx | 075401 AB4 DILTIAZEM HYDROCHLORIDE Capsule, Extended Release; 360MG TAZTIA XT Andrx | 020062 AB3 DILTIAZEM HYDROCHLORIDE Capsule, Extended Release; 120MG CARDIZEM CD AVENTIS 019471 AB1 DILTIAZEM HYDROCHLORIDE Capsule, Extended Release; 120MG CARDIZEM SR AVENTIS 020062 AB3 DILTIAZEM HYDROCHLORIDE Capsule, Extended Release; 180MG CARDIZEM CD AVENTIS 020062 AB3 DILTIAZEM HYDROCHLORIDE Capsule, Extended Release; 240MG CARDIZEM CD AVENTIS 020062 AB3 DILTIAZEM HYDROCHLORIDE Capsule, Extended Release; 300MG CARDIZEM CD AVENTIS 019471 AB1 DILTIAZEM HYDROCHLORIDE Capsule, Extended Release; 60MG CARDIZEM SR AVENTIS 019471 AB1 DILTIAZEM HYDROCHLORIDE Capsule, Extended Release; 90MG CARDIZEM SR AVENTIS 020939 AB3 DILTIAZEM HYDROCHLORIDE Capsule, Extended Release; 120MG DILTIAZEM HCL BIOVAIL | 020401 AB4 DILTIAZEM HYDROCHLORIDE Capsule, Extended Release; 120MG TIAZAC BIOVAIL | 075116 AB3 DILTIAZEM HYDROCHLORIDE Capsule, Extended Release; 120MG DILTIAZEM HCL BIOVAIL | 074845 AB1 DILTIAZEM HYDROCHLORIDE Capsule, Extended Release; 120MG DILTIAZEM HCL BIOVAIL | 075116 AB3 DILTIAZEM HYDROCHLORIDE Capsule, Extended Release; 180MG DILTIAZEM HCL BIOVAIL | 020401 AB4 DILTIAZEM HYDROCHLORIDE Capsule, Extended Release; 180MG TIAZAC BIOVAIL | 020939 AB3 DILTIAZEM HYDROCHLORIDE Capsule, Extended Release; 180MG DILTIAZEM HCL BIOVAIL | 020939 AB3 DILTIAZEM HYDROCHLORIDE Capsule, Extended Release; 240MG DILTIAZEM HCL BIOVAIL | 020401 AB4 DILTIAZEM HYDROCHLORIDE Capsule, Extended Release; 240MG TIAZAC BIOVAIL | 075116 AB3 DILTIAZEM HYDROCHLORIDE Capsule, Extended Release; 240MG DILTIAZEM HCL BIOVAIL | 075116 AB3 DILTIAZEM HYDROCHLORIDE Capsule, Extended Release; 300MG DILTIAZEM HCL BIOVAIL | 020401 AB4 DILTIAZEM HYDROCHLORIDE Capsule, Extended Release; 300MG TIAZAC BIOVAIL | 020939 AB3 DILTIAZEM HYDROCHLORIDE Capsule, Extended Release; 300MG DILTIAZEM HCL BIOVAIL | 020401 AB4 DILTIAZEM HYDROCHLORIDE Capsule, Extended Release; 360MG TIAZAC BIOVAIL | 020401 DILTIAZEM HYDROCHLORIDE Capsule, Extended Release; 420MG TIAZAC BIOVAIL | 074845 AB1 DILTIAZEM HYDROCHLORIDE Capsule, Extended Release; 60MG DILTIAZEM HCL BIOVAIL | 074845 AB1 DILTIAZEM HYDROCHLORIDE Capsule, Extended Release; 90MG DILTIAZEM HCL BIOVAIL | 075124 AB2 DILTIAZEM HYDROCHLORIDE Capsule, Extended Release; 120MG DILTIAZEM HCL Mylan | 074910 AB1 DILTIAZEM HYDROCHLORIDE Capsule, Extended Release; 120MG DILTIAZEM HCL Mylan | 075124 AB2 DILTIAZEM HYDROCHLORIDE Capsule, Extended Release; 180MG DILTIAZEM HCL Mylan | 075124 AB2 DILTIAZEM HYDROCHLORIDE Capsule, Extended Release; 240MG DILTIAZEM HCL Mylan | 074910 AB1 DILTIAZEM HYDROCHLORIDE Capsule, Extended Release; 60MG DILTIAZEM HCL Mylan | 074910 AB1 DILTIAZEM HYDROCHLORIDE Capsule, Extended Release; 90MG DILTIAZEM HCL Mylan | 074984 AB3 DILTIAZEM HYDROCHLORIDE Capsule, Extended Release; 120MG DILTIAZEM HCL Purepac 074984 AB3 DILTIAZEM HYDROCHLORIDE Capsule, Extended Release; 180MG DILTIAZEM HCL Purepac 074984 AB3 DILTIAZEM HYDROCHLORIDE Capsule, Extended Release; 240MG DILTIAZEM HCL Purepac 074984 AB3 DILTIAZEM HYDROCHLORIDE Capsule, Extended Release; 300MG DILTIAZEM HCL Purepac 074079 AB1 DILTIAZEM HYDROCHLORIDE Capsule, Extended Release; 120MG DILTIAZEM HCL Teva | 074079 AB1 DILTIAZEM HYDROCHLORIDE Capsule, Extended Release; 60MG DILTIAZEM HCL Teva | 074079 AB1 DILTIAZEM HYDROCHLORIDE Capsule, Extended Release; 90MG DILTIAZEM HCL Teva | 074943 AB2 DILTIAZEM HYDROCHLORIDE Capsule, Extended Release; 120MG DILTIAZEM HCL Torpharm | 074943 AB2 DILTIAZEM HYDROCHLORIDE Capsule, Extended Release; 180MG DILTIAZEM HCL Torpharm | 074943 AB2 DILTIAZEM HYDROCHLORIDE Capsule, Extended Release; 240MG DILTIAZEM HCL Torpharm | 020092 AB2 DILTIAZEM HYDROCHLORIDE Capsule, Extended Release; 120MG DILACOR XR Watson 020092 AB2 DILTIAZEM HYDROCHLORIDE Capsule, Extended Release; 180MG DILACOR XR Watson 020092 AB2 DILTIAZEM HYDROCHLORIDE Capsule, Extended Release; 240MG DILACOR XR Watson 075853 DILTIAZEM HYDROCHLORIDE Injection 100MG/VIAL DILTIAZEM HCL Abbott 074941 DILTIAZEM HYDROCHLORIDE Injection 5MG/ML DILTIAZEM HCL Abbott 075004 DILTIAZEM HYDROCHLORIDE Injection 5MG/ML DILTIAZEM HCL Abbott 075375 DILTIAZEM HYDROCHLORIDE Injection 5MG/ML DILTIAZEM HCL Apotex 020792 DILTIAZEM HYDROCHLORIDE Injection 100MG/VIAL CARDIZEM AVENTIS 074617 DILTIAZEM HYDROCHLORIDE Injection 5MG/ML DILTIAZEM HCL Bedford 020027 DILTIAZEM HYDROCHLORIDE Injection 25MG/VIAL CARDIZEM BIOVAIL | 020027 DILTIAZEM HYDROCHLORIDE Injection 5MG/ML CARDIZEM BIOVAIL | 074894 DILTIAZEM HYDROCHLORIDE Injection 10MG/ML DILTIAZEM HCL Gensia Sicor 074894 DILTIAZEM HYDROCHLORIDE Injection 5MG/ML DILTIAZEM HCL Gensia Sicor 075749 DILTIAZEM HYDROCHLORIDE Injection 5MG/ML DILTIAZEM HCL INTL MEDICATION | 075106 DILTIAZEM HYDROCHLORIDE Injection 5MG/ML DILTIAZEM HCL MERIDIAN MEDCL TECHN | 075086 DILTIAZEM HYDROCHLORIDE Injection 5MG/ML DILTIAZEM HCL TAYLOR 021392 DILTIAZEM HYDROCHLORIDE Tablet, Extended Release; 120MG CARDIZEM LA BIOVAIL | 021392 DILTIAZEM HYDROCHLORIDE Tablet, Extended Release; 180MG CARDIZEM LA BIOVAIL | 021392 DILTIAZEM HYDROCHLORIDE Tablet, Extended Release; 240MG CARDIZEM LA BIOVAIL | 021392 DILTIAZEM HYDROCHLORIDE Tablet, Extended Release; 300MG CARDIZEM LA BIOVAIL | 021392 DILTIAZEM HYDROCHLORIDE Tablet, Extended Release; 360MG CARDIZEM LA BIOVAIL | 021392 DILTIAZEM HYDROCHLORIDE Tablet, Extended Release; 420MG CARDIZEM LA BIOVAIL | 074051 DILTIAZEM HYDROCHLORIDE Tablet; 120MG DILTIAZEM HCL APOTHECON | 074051 DILTIAZEM HYDROCHLORIDE Tablet; 30MG DILTIAZEM HCL APOTHECON | 074051 DILTIAZEM HYDROCHLORIDE Tablet; 60MG DILTIAZEM HCL APOTHECON | 074051 DILTIAZEM HYDROCHLORIDE Tablet; 90MG DILTIAZEM HCL APOTHECON | 018602 DILTIAZEM HYDROCHLORIDE Tablet; 120MG CARDIZEM AVENTIS 018602 DILTIAZEM HYDROCHLORIDE Tablet; 30MG CARDIZEM AVENTIS 018602 DILTIAZEM HYDROCHLORIDE Tablet; 60MG CARDIZEM AVENTIS 018602 DILTIAZEM HYDROCHLORIDE Tablet; 90MG CARDIZEM AVENTIS 074093 DILTIAZEM HYDROCHLORIDE Tablet; 120MG DILTIAZEM HCL CLONMEL 074093 DILTIAZEM HYDROCHLORIDE Tablet; 30MG DILTIAZEM HCL CLONMEL 074093 DILTIAZEM HYDROCHLORIDE Tablet; 60MG DILTIAZEM HCL CLONMEL 074093 DILTIAZEM HYDROCHLORIDE Tablet; 90MG DILTIAZEM HCL CLONMEL 074067 DILTIAZEM HYDROCHLORIDE Tablet; 120MG DILTIAZEM HCL Copley 074067 DILTIAZEM HYDROCHLORIDE Tablet; 30MG DILTIAZEM HCL Copley 074067 DILTIAZEM HYDROCHLORIDE Tablet; 60MG DILTIAZEM HCL Copley 074067 DILTIAZEM HYDROCHLORIDE Tablet; 90MG DILTIAZEM HCL Copley 074168 DILTIAZEM HYDROCHLORIDE Tablet; 120MG DILTIAZEM HCL Ivax 074168 DILTIAZEM HYDROCHLORIDE Tablet; 30MG DILTIAZEM HCL Ivax 074168 DILTIAZEM HYDROCHLORIDE Tablet; 60MG DILTIAZEM HCL Ivax 074168 DILTIAZEM HYDROCHLORIDE Tablet; 90MG DILTIAZEM HCL Ivax 072838 DILTIAZEM HYDROCHLORIDE Tablet; 120MG DILTIAZEM HCL Mylan | 073185 DILTIAZEM HYDROCHLORIDE Tablet; 30MG DILTIAZEM HCL Mylan | 073186 DILTIAZEM HYDROCHLORIDE Tablet; 60MG DILTIAZEM HCL Mylan | 072837 DILTIAZEM HYDROCHLORIDE Tablet; 90MG DILTIAZEM HCL Mylan | 074185 DILTIAZEM HYDROCHLORIDE Tablet; 120MG DILTIAZEM HCL Teva | 074185 DILTIAZEM HYDROCHLORIDE Tablet; 30MG DILTIAZEM HCL Teva | 074185 DILTIAZEM HYDROCHLORIDE Tablet; 60MG DILTIAZEM HCL Teva | 074185 DILTIAZEM HYDROCHLORIDE Tablet; 90MG DILTIAZEM HCL Teva | 020507 DILTIAZEM MALATE; ENALAPRIL MALEATE Tablet, Extended Release; 180MG HCL;5MG TECZEM BIOVAIL Cardizem LA (diltiazem hydrochloride) Extended-Release Tablets, Biovail Dilt-CD (Diltiazem Hydrochloride USP) Extended-release Capsules, Torpharm | Cardizem (diltiazem hydrochloride) Injectable/Lyo-ject, Biovail, Labeling Revision | Diltzac (Diltiazem Hydrochloride) Extended Release Capsules, Apotex, Approval | Diltiazem Hydrochloride Extended-Release Capsules, KV Pharma, Approval | Cardizem LA (diltiazem hydrochloride) Extended-Release Tablets, Biovail, Labeling Revision | Tiazac (diltiazem hydrochloride) Extended-Release Capsules, Biovail, Labeling Revision | Diltiazem Hydrochloride Injection, Baxter Healthcare Corp., Approval | Diltiazem Hydrochloride Extended-Release Tablets, Watson Laboratories, Inc., Approval | Dilacor XR (diltiazem hydrochloride) Extended-Release Capsules, Watson Laboratories, Labeling Revision | Diltiazem Hydrochloride Extended-Release Capsules, Sun Pharmaceutical, Approval | Cardizem (diltiazem hydrochloride) Tablets, Biovail, Labeling Revision | Cardizem CD (diltiazem hydrochloride) Extended-Release Capsules, Biovail, Labeling Revision | Cardizem LA (diltiazem hydrochloride) Extended-Release Tablets, Biovail, Labeling Revision | Tiazac (diltiazem hydrochloride) Extended-Release Capsules, Biovail, Labeling Revision | Dilacor XR (diltiazem hydrochloride) Extended Release Capsules, Watson Laboratories, Inc., Labeling Revision | Diltiazem Hydrochloride Extended-Release Capsules, Sun Pharma Global, 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