اطلاعات داروی نمایش داده شده مستقیما از دیتابیس اطلاعات دارویی سازمان غذا و دارو آمریکا (FDA) استخراج می شود و مرتبا به روز رسانی می شود
داروی نمایش داده شده مورد تایید FDA می باشد و اطلاعات ثبت آن در زیر قابل مشاهده است
CLONIDINE HYDROCHLORIDE از شرکت LUPIN LTD
Abbreviated New Drug Application (ANDA): 209285
Company: LUPIN LTD
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| CLONIDINE HYDROCHLORIDE | CLONIDINE HYDROCHLORIDE | 0.1MG | TABLET, EXTENDED RELEASE;ORAL | Prescription |
AB1 |
No | No |
Original Approvals or Tentative Approvals
| Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
|---|---|---|---|---|---|---|---|
| 10/23/2017 | ORIG-1 | Approval |
STANDARD |
|
Label is not available on this site. |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 05/21/2020 | SUPPL-3 | Labeling-Package Insert, Labeling-Patient Package Insert |
Label is not available on this site. |
||
| 05/21/2020 | SUPPL-1 | Labeling-Package Insert |
Label is not available on this site. |
CLONIDINE HYDROCHLORIDE
TABLET, EXTENDED RELEASE;ORAL; 0.1MG
TE Code = AB1
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| CLONIDINE HYDROCHLORIDE | CLONIDINE HYDROCHLORIDE | 0.1MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB1 | 203320 | ACTAVIS ELIZABETH |
| CLONIDINE HYDROCHLORIDE | CLONIDINE HYDROCHLORIDE | 0.1MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB1 | 209686 | AJANTA PHARMA LTD |
| CLONIDINE HYDROCHLORIDE | CLONIDINE HYDROCHLORIDE | 0.1MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB1 | 210052 | AMNEAL PHARMS NY |
| CLONIDINE HYDROCHLORIDE | CLONIDINE HYDROCHLORIDE | 0.1MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB1 | 202984 | ANCHEN PHARMS |
| CLONIDINE HYDROCHLORIDE | CLONIDINE HYDROCHLORIDE | 0.1MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB1 | 210338 | JUBILANT GENERICS |
| CLONIDINE HYDROCHLORIDE | CLONIDINE HYDROCHLORIDE | 0.1MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB1 | 209285 | LUPIN LTD |
| CLONIDINE HYDROCHLORIDE | CLONIDINE HYDROCHLORIDE | 0.1MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB1 | 210680 | MAYNE PHARMA INC |
| CLONIDINE HYDROCHLORIDE | CLONIDINE HYDROCHLORIDE | 0.1MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB1 | 209675 | NOVAST LABS |
| CLONIDINE HYDROCHLORIDE | CLONIDINE HYDROCHLORIDE | 0.1MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB1 | 211433 | UPSHER SMITH LABS |
| CLONIDINE HYDROCHLORIDE | CLONIDINE HYDROCHLORIDE | 0.1MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB1 | 209757 | XIAMEN LP PHARM CO |
| KAPVAY | CLONIDINE HYDROCHLORIDE | 0.1MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | Yes | AB1 | 022331 | CONCORDIA PHARMS INC |
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