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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
For a link to the official website for this drug, please click here. Find the latest approval information using this index.
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