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 |
|---|
| 2002/05/20 |
SUPPL-24（补充） |
Approval |
Manufacturing (CMC) |
|
|
|
| 1999/12/21 |
SUPPL-23（补充） |
Approval |
Manufacturing (CMC) |
|
|
|
| 1999/11/10 |
SUPPL-22（补充） |
Approval |
Manufacturing (CMC) |
|
|
|
| 1999/11/10 |
SUPPL-21（补充） |
Approval |
Manufacturing (CMC) |
|
|
|
| 1999/10/01 |
SUPPL-20（补充） |
Approval |
Manufacturing (CMC) |
|
|
|
| 1999/10/01 |
SUPPL-19（补充） |
Approval |
Manufacturing (CMC) |
|
|
|
| 1999/05/20 |
SUPPL-18（补充） |
Approval |
Manufacturing (CMC) |
|
|
|
| 1998/12/01 |
SUPPL-17（补充） |
Approval |
Manufacturing (CMC) |
|
|
|
| 1998/07/30 |
SUPPL-16（补充） |
Approval |
Manufacturing (CMC) |
|
|
|
| 1997/10/10 |
SUPPL-15（补充） |
Approval |
Manufacturing (CMC) |
|
|
|
| 1996/05/08 |
SUPPL-14（补充） |
Approval |
Manufacturing (CMC) |
|
|
|
| 1994/12/23 |
SUPPL-13（补充） |
Approval |
Manufacturing (CMC) |
|
|
|
| 1994/10/11 |
SUPPL-12（补充） |
Approval |
Manufacturing (CMC) |
|
|
|
| 1992/04/03 |
SUPPL-11（补充） |
Approval |
Manufacturing (CMC) |
|
|
|
| 1992/04/03 |
SUPPL-9（补充） |
Approval |
Manufacturing (CMC) |
|
|
|
| 1991/10/16 |
SUPPL-8（补充） |
Approval |
Labeling |
|
|
|
| 1989/02/14 |
SUPPL-7（补充） |
Approval |
Manufacturing (CMC) |
|
|
|
| 1974/12/24 |
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:TETRACYCLINE HYDROCHLORIDE 剂型/给药途径:CAPSULE;ORAL 规格:250MG 治疗等效代码:AB
| 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 |
|---|
| 050278 |
003 |
NDA |
ACHROMYCIN V |
TETRACYCLINE HYDROCHLORIDE |
CAPSULE;ORAL |
250MG |
Prescription |
Yes |
No |
AB |
Approved Prior to Jan 1, 1982
|
AVET |
| 061837 |
001 |
ANDA |
TETRACYCLINE HYDROCHLORIDE |
TETRACYCLINE HYDROCHLORIDE |
CAPSULE;ORAL |
250MG |
Prescription |
No |
No |
AB |
Approved Prior to Jan 1, 1982
|
WATSON LABS |
| 062752 |
001 |
ANDA |
TETRACYCLINE HYDROCHLORIDE |
TETRACYCLINE HYDROCHLORIDE |
CAPSULE;ORAL |
250MG |
Prescription |
No |
No |
AB |
1988/08/12
|
CHARTWELL TETRA |
| 210674 |
001 |
ANDA |
TETRACYCLINE HYDROCHLORIDE |
TETRACYCLINE HYDROCHLORIDE |
CAPSULE;ORAL |
250MG |
Prescription |
No |
No |
AB |
2018/09/18
|
AMNEAL PHARMS NY |
| 210662 |
001 |
ANDA |
TETRACYCLINE HYDROCHLORIDE |
TETRACYCLINE HYDROCHLORIDE |
CAPSULE;ORAL |
250MG |
Prescription |
No |
No |
AB |
2018/11/07
|
BRECKENRIDGE |
| 212635 |
001 |
ANDA |
TETRACYCLINE HYDROCHLORIDE |
TETRACYCLINE HYDROCHLORIDE |
CAPSULE;ORAL |
250MG |
Prescription |
No |
No |
AB |
2020/03/03
|
ESJAY PHARMA |
活性成分:TETRACYCLINE HYDROCHLORIDE 剂型/给药途径:CAPSULE;ORAL 规格:500MG 治疗等效代码:AB
| 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 |
|---|
| 050278 |
001 |
NDA |
ACHROMYCIN V |
TETRACYCLINE HYDROCHLORIDE |
CAPSULE;ORAL |
500MG |
Prescription |
Yes |
No |
AB |
Approved Prior to Jan 1, 1982
|
AVET |
| 061837 |
002 |
ANDA |
TETRACYCLINE HYDROCHLORIDE |
TETRACYCLINE HYDROCHLORIDE |
CAPSULE;ORAL |
500MG |
Prescription |
No |
No |
AB |
Approved Prior to Jan 1, 1982
|
WATSON LABS |
| 062752 |
002 |
ANDA |
TETRACYCLINE HYDROCHLORIDE |
TETRACYCLINE HYDROCHLORIDE |
CAPSULE;ORAL |
500MG |
Prescription |
No |
No |
AB |
1988/08/12
|
CHARTWELL TETRA |
| 210674 |
002 |
ANDA |
TETRACYCLINE HYDROCHLORIDE |
TETRACYCLINE HYDROCHLORIDE |
CAPSULE;ORAL |
500MG |
Prescription |
No |
Yes |
AB |
2018/09/18
|
AMNEAL PHARMS NY |
| 210662 |
002 |
ANDA |
TETRACYCLINE HYDROCHLORIDE |
TETRACYCLINE HYDROCHLORIDE |
CAPSULE;ORAL |
500MG |
Prescription |
No |
No |
AB |
2018/11/07
|
BRECKENRIDGE |
| 212635 |
002 |
ANDA |
TETRACYCLINE HYDROCHLORIDE |
TETRACYCLINE HYDROCHLORIDE |
CAPSULE;ORAL |
500MG |
Prescription |
No |
No |
AB |
2020/03/03
|
ESJAY PHARMA |