批准日期,申请提交历史,通知信,药品说明书,审评文件等信息
提交状态日期 | 提交号 | 审批结论 | 申请内容分类 | 审评优先级;罕用药状态 | 通知信、审评文件、说明书、包装标签 | 备注 |
2012/02/04 |
SUPPL-36(补充) |
Approval |
Manufacturing (CMC) |
|
|
|
2011/08/19 |
SUPPL-35(补充) |
Approval |
Labeling |
|
|
|
2008/07/17 |
SUPPL-23(补充) |
Approval |
Labeling |
|
|
|
2002/11/04 |
SUPPL-11(补充) |
Approval |
Manufacturing (CMC) |
|
|
|
2002/07/31 |
SUPPL-10(补充) |
Approval |
Manufacturing (CMC) |
|
|
|
2002/02/11 |
SUPPL-8(补充) |
Approval |
Manufacturing (CMC) |
|
|
|
2002/02/11 |
SUPPL-5(补充) |
Approval |
Manufacturing (CMC) |
|
|
|
2001/11/02 |
SUPPL-7(补充) |
Approval |
Manufacturing (CMC) |
|
|
|
2001/10/01 |
SUPPL-6(补充) |
Approval |
Manufacturing (CMC) |
|
|
|
2001/02/15 |
SUPPL-4(补充) |
Approval |
Manufacturing (CMC) |
|
|
|
2000/12/14 |
SUPPL-3(补充) |
Approval |
Manufacturing (CMC) |
|
|
|
2000/12/14 |
SUPPL-2(补充) |
Approval |
Manufacturing (CMC) |
|
|
|
2000/09/18 |
SUPPL-1(补充) |
Approval |
Manufacturing (CMC) |
|
|
|
1999/12/20 |
ORIG-1(原始申请) |
Approval |
|
|
|
|
与本品相关的专利信息(来自FDA橙皮书Orange Book)
关联产品号 | 专利号 | 专利过期日 | 是否物质专利 | 是否产品专利 | 专利用途代码 | 撤销请求 | 提交日期 | 专利下载 | 备注 |
无 |
与本品治疗等效的药品
活性成分:DILTIAZEM HYDROCHLORIDE 剂型/给药途径:CAPSULE, EXTENDED RELEASE;ORAL 规格:120MG 治疗等效代码:AB3
申请号 | 产品号 | 申请类型 | 商品名 | 活性成分 | 剂型/给药途径 | 规格 | 市场状态 | RLD | RS | TE Code | 产品号批准日期 | 申请人 |
020062 |
001 |
NDA |
CARDIZEM CD |
DILTIAZEM HYDROCHLORIDE |
CAPSULE, EXTENDED RELEASE;ORAL |
120MG |
Prescription |
Yes |
No |
AB3 |
1992/08/10
|
BAUSCH |
074752 |
002 |
ANDA |
CARTIA XT |
DILTIAZEM HYDROCHLORIDE |
CAPSULE, EXTENDED RELEASE;ORAL |
120MG |
Prescription |
No |
No |
AB3 |
1998/07/09
|
ACTAVIS LABS FL INC |
074984 |
001 |
ANDA |
DILTIAZEM HYDROCHLORIDE |
DILTIAZEM HYDROCHLORIDE |
CAPSULE, EXTENDED RELEASE;ORAL |
120MG |
Prescription |
No |
No |
AB3 |
1999/12/20
|
ENDO OPERATIONS |
075116 |
001 |
ANDA |
DILTIAZEM HYDROCHLORIDE |
DILTIAZEM HYDROCHLORIDE |
CAPSULE, EXTENDED RELEASE;ORAL |
120MG |
Prescription |
No |
No |
AB3 |
1999/12/23
|
VALEANT PHARMS NORTH |
090492 |
001 |
ANDA |
DILTIAZEM HYDROCHLORIDE |
DILTIAZEM HYDROCHLORIDE |
CAPSULE, EXTENDED RELEASE;ORAL |
120MG |
Discontinued |
No |
No |
AB3 |
2011/10/28
|
SUN PHARM |
203023 |
001 |
ANDA |
DILTIAZEM HYDROCHLORIDE |
DILTIAZEM HYDROCHLORIDE |
CAPSULE, EXTENDED RELEASE;ORAL |
120MG |
Prescription |
No |
No |
AB3 |
2017/06/08
|
SUN PHARM |
206534 |
001 |
ANDA |
DILTIAZEM HYDROCHLORIDE |
DILTIAZEM HYDROCHLORIDE |
CAPSULE, EXTENDED RELEASE;ORAL |
120MG |
Prescription |
No |
No |
AB3 |
2017/08/08
|
ZYDUS PHARMS |
205231 |
001 |
ANDA |
DILTIAZEM HYDROCHLORIDE |
DILTIAZEM HYDROCHLORIDE |
CAPSULE, EXTENDED RELEASE;ORAL |
120MG |
Prescription |
No |
No |
AB3 |
2018/08/30
|
TWI PHARMS |
208783 |
001 |
ANDA |
DILTIAZEM HYDROCHLORIDE |
DILTIAZEM HYDROCHLORIDE |
CAPSULE, EXTENDED RELEASE;ORAL |
120MG |
Prescription |
No |
No |
AB3 |
2019/06/14
|
NOVAST LABS |
216968 |
001 |
ANDA |
DILTIAZEM HYDROCHLORIDE |
DILTIAZEM HYDROCHLORIDE |
CAPSULE, EXTENDED RELEASE;ORAL |
120MG |
Prescription |
No |
No |
AB3 |
2024/11/08
|
ALEMBIC |
活性成分:DILTIAZEM HYDROCHLORIDE 剂型/给药途径:CAPSULE, EXTENDED RELEASE;ORAL 规格:180MG 治疗等效代码:AB3
申请号 | 产品号 | 申请类型 | 商品名 | 活性成分 | 剂型/给药途径 | 规格 | 市场状态 | RLD | RS | TE Code | 产品号批准日期 | 申请人 |
020062 |
002 |
NDA |
CARDIZEM CD |
DILTIAZEM HYDROCHLORIDE |
CAPSULE, EXTENDED RELEASE;ORAL |
180MG |
Prescription |
Yes |
No |
AB3 |
1991/12/27
|
BAUSCH |
074752 |
001 |
ANDA |
CARTIA XT |
DILTIAZEM HYDROCHLORIDE |
CAPSULE, EXTENDED RELEASE;ORAL |
180MG |
Prescription |
No |
No |
AB3 |
1998/07/09
|
ACTAVIS LABS FL INC |
074984 |
002 |
ANDA |
DILTIAZEM HYDROCHLORIDE |
DILTIAZEM HYDROCHLORIDE |
CAPSULE, EXTENDED RELEASE;ORAL |
180MG |
Prescription |
No |
No |
AB3 |
1999/12/20
|
ENDO OPERATIONS |
075116 |
002 |
ANDA |
DILTIAZEM HYDROCHLORIDE |
DILTIAZEM HYDROCHLORIDE |
CAPSULE, EXTENDED RELEASE;ORAL |
180MG |
Prescription |
No |
No |
AB3 |
1999/12/23
|
VALEANT PHARMS NORTH |
090492 |
002 |
ANDA |
DILTIAZEM HYDROCHLORIDE |
DILTIAZEM HYDROCHLORIDE |
CAPSULE, EXTENDED RELEASE;ORAL |
180MG |
Discontinued |
No |
No |
AB3 |
2011/10/28
|
SUN PHARM |
203023 |
002 |
ANDA |
DILTIAZEM HYDROCHLORIDE |
DILTIAZEM HYDROCHLORIDE |
CAPSULE, EXTENDED RELEASE;ORAL |
180MG |
Prescription |
No |
No |
AB3 |
2017/06/08
|
SUN PHARM |
206534 |
002 |
ANDA |
DILTIAZEM HYDROCHLORIDE |
DILTIAZEM HYDROCHLORIDE |
CAPSULE, EXTENDED RELEASE;ORAL |
180MG |
Prescription |
No |
No |
AB3 |
2017/08/08
|
ZYDUS PHARMS |
205231 |
002 |
ANDA |
DILTIAZEM HYDROCHLORIDE |
DILTIAZEM HYDROCHLORIDE |
CAPSULE, EXTENDED RELEASE;ORAL |
180MG |
Prescription |
No |
No |
AB3 |
2018/08/30
|
TWI PHARMS |
208783 |
002 |
ANDA |
DILTIAZEM HYDROCHLORIDE |
DILTIAZEM HYDROCHLORIDE |
CAPSULE, EXTENDED RELEASE;ORAL |
180MG |
Prescription |
No |
No |
AB3 |
2019/06/14
|
NOVAST LABS |
216968 |
002 |
ANDA |
DILTIAZEM HYDROCHLORIDE |
DILTIAZEM HYDROCHLORIDE |
CAPSULE, EXTENDED RELEASE;ORAL |
180MG |
Prescription |
No |
No |
AB3 |
2024/11/08
|
ALEMBIC |
活性成分:DILTIAZEM HYDROCHLORIDE 剂型/给药途径:CAPSULE, EXTENDED RELEASE;ORAL 规格:240MG 治疗等效代码:AB3
申请号 | 产品号 | 申请类型 | 商品名 | 活性成分 | 剂型/给药途径 | 规格 | 市场状态 | RLD | RS | TE Code | 产品号批准日期 | 申请人 |
020062 |
003 |
NDA |
CARDIZEM CD |
DILTIAZEM HYDROCHLORIDE |
CAPSULE, EXTENDED RELEASE;ORAL |
240MG |
Prescription |
Yes |
No |
AB3 |
1991/12/27
|
BAUSCH |
074752 |
003 |
ANDA |
CARTIA XT |
DILTIAZEM HYDROCHLORIDE |
CAPSULE, EXTENDED RELEASE;ORAL |
240MG |
Prescription |
No |
No |
AB3 |
1998/07/09
|
ACTAVIS LABS FL INC |
074984 |
003 |
ANDA |
DILTIAZEM HYDROCHLORIDE |
DILTIAZEM HYDROCHLORIDE |
CAPSULE, EXTENDED RELEASE;ORAL |
240MG |
Prescription |
No |
No |
AB3 |
1999/12/20
|
ENDO OPERATIONS |
075116 |
003 |
ANDA |
DILTIAZEM HYDROCHLORIDE |
DILTIAZEM HYDROCHLORIDE |
CAPSULE, EXTENDED RELEASE;ORAL |
240MG |
Prescription |
No |
No |
AB3 |
1999/12/23
|
VALEANT PHARMS NORTH |
090492 |
003 |
ANDA |
DILTIAZEM HYDROCHLORIDE |
DILTIAZEM HYDROCHLORIDE |
CAPSULE, EXTENDED RELEASE;ORAL |
240MG |
Discontinued |
No |
No |
AB3 |
2011/10/28
|
SUN PHARM |
203023 |
003 |
ANDA |
DILTIAZEM HYDROCHLORIDE |
DILTIAZEM HYDROCHLORIDE |
CAPSULE, EXTENDED RELEASE;ORAL |
240MG |
Prescription |
No |
No |
AB3 |
2017/06/08
|
SUN PHARM |
206534 |
003 |
ANDA |
DILTIAZEM HYDROCHLORIDE |
DILTIAZEM HYDROCHLORIDE |
CAPSULE, EXTENDED RELEASE;ORAL |
240MG |
Prescription |
No |
No |
AB3 |
2017/08/08
|
ZYDUS PHARMS |
205231 |
003 |
ANDA |
DILTIAZEM HYDROCHLORIDE |
DILTIAZEM HYDROCHLORIDE |
CAPSULE, EXTENDED RELEASE;ORAL |
240MG |
Prescription |
No |
No |
AB3 |
2018/08/30
|
TWI PHARMS |
208783 |
003 |
ANDA |
DILTIAZEM HYDROCHLORIDE |
DILTIAZEM HYDROCHLORIDE |
CAPSULE, EXTENDED RELEASE;ORAL |
240MG |
Prescription |
No |
No |
AB3 |
2019/06/14
|
NOVAST LABS |
216968 |
003 |
ANDA |
DILTIAZEM HYDROCHLORIDE |
DILTIAZEM HYDROCHLORIDE |
CAPSULE, EXTENDED RELEASE;ORAL |
240MG |
Prescription |
No |
No |
AB3 |
2024/11/08
|
ALEMBIC |
活性成分:DILTIAZEM HYDROCHLORIDE 剂型/给药途径:CAPSULE, EXTENDED RELEASE;ORAL 规格:300MG 治疗等效代码:AB3
申请号 | 产品号 | 申请类型 | 商品名 | 活性成分 | 剂型/给药途径 | 规格 | 市场状态 | RLD | RS | TE Code | 产品号批准日期 | 申请人 |
020062 |
004 |
NDA |
CARDIZEM CD |
DILTIAZEM HYDROCHLORIDE |
CAPSULE, EXTENDED RELEASE;ORAL |
300MG |
Prescription |
Yes |
No |
AB3 |
1991/12/27
|
BAUSCH |
074752 |
004 |
ANDA |
CARTIA XT |
DILTIAZEM HYDROCHLORIDE |
CAPSULE, EXTENDED RELEASE;ORAL |
300MG |
Prescription |
No |
No |
AB3 |
1998/07/09
|
ACTAVIS LABS FL INC |
074984 |
004 |
ANDA |
DILTIAZEM HYDROCHLORIDE |
DILTIAZEM HYDROCHLORIDE |
CAPSULE, EXTENDED RELEASE;ORAL |
300MG |
Prescription |
No |
No |
AB3 |
1999/12/20
|
ENDO OPERATIONS |
075116 |
004 |
ANDA |
DILTIAZEM HYDROCHLORIDE |
DILTIAZEM HYDROCHLORIDE |
CAPSULE, EXTENDED RELEASE;ORAL |
300MG |
Prescription |
No |
No |
AB3 |
1999/12/23
|
VALEANT PHARMS NORTH |
090492 |
004 |
ANDA |
DILTIAZEM HYDROCHLORIDE |
DILTIAZEM HYDROCHLORIDE |
CAPSULE, EXTENDED RELEASE;ORAL |
300MG |
Discontinued |
No |
No |
AB3 |
2011/10/28
|
SUN PHARM |
203023 |
004 |
ANDA |
DILTIAZEM HYDROCHLORIDE |
DILTIAZEM HYDROCHLORIDE |
CAPSULE, EXTENDED RELEASE;ORAL |
300MG |
Prescription |
No |
No |
AB3 |
2017/06/08
|
SUN PHARM |
206534 |
004 |
ANDA |
DILTIAZEM HYDROCHLORIDE |
DILTIAZEM HYDROCHLORIDE |
CAPSULE, EXTENDED RELEASE;ORAL |
300MG |
Prescription |
No |
No |
AB3 |
2017/08/08
|
ZYDUS PHARMS |
205231 |
004 |
ANDA |
DILTIAZEM HYDROCHLORIDE |
DILTIAZEM HYDROCHLORIDE |
CAPSULE, EXTENDED RELEASE;ORAL |
300MG |
Prescription |
No |
No |
AB3 |
2018/08/30
|
TWI PHARMS |
208783 |
004 |
ANDA |
DILTIAZEM HYDROCHLORIDE |
DILTIAZEM HYDROCHLORIDE |
CAPSULE, EXTENDED RELEASE;ORAL |
300MG |
Prescription |
No |
No |
AB3 |
2019/06/14
|
NOVAST LABS |
216968 |
004 |
ANDA |
DILTIAZEM HYDROCHLORIDE |
DILTIAZEM HYDROCHLORIDE |
CAPSULE, EXTENDED RELEASE;ORAL |
300MG |
Prescription |
No |
No |
AB3 |
2024/11/08
|
ALEMBIC |