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 ACTAVIS ELIZABETH
Abbreviated New Drug Application (ANDA): 070976
Company: ACTAVIS ELIZABETH
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| CLONIDINE HYDROCHLORIDE | CLONIDINE HYDROCHLORIDE | 0.3MG | TABLET;ORAL | Prescription |
AB |
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 |
|---|---|---|---|---|---|---|---|
| 12/16/1986 | ORIG-1 | Approval |
|
Label is not available on this site. |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 01/16/2013 | SUPPL-40 | Labeling-Package Insert |
Label is not available on this site. |
||
| 06/23/2010 | SUPPL-34 | Labeling-Package Insert |
Label is not available on this site. |
||
| 08/08/2002 | SUPPL-15 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 11/02/2001 | SUPPL-14 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 03/20/2000 | SUPPL-13 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
||
| 03/20/2000 | SUPPL-12 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
||
| 10/21/1999 | SUPPL-11 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 02/18/1997 | SUPPL-10 | Labeling |
Label is not available on this site. |
||
| 01/18/1996 | SUPPL-8 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 02/04/1992 | SUPPL-7 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 10/13/1989 | SUPPL-6 | Labeling |
Label is not available on this site. |
||
| 11/17/1988 | SUPPL-5 | Labeling |
Label is not available on this site. |
||
| 05/10/1988 | SUPPL-4 | Labeling |
Label is not available on this site. |
||
| 01/28/1988 | SUPPL-3 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 01/28/1988 | SUPPL-2 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 01/28/1988 | SUPPL-1 | Manufacturing (CMC) |
Label is not available on this site. |
CLONIDINE HYDROCHLORIDE
TABLET;ORAL; 0.3MG
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| CATAPRES | CLONIDINE HYDROCHLORIDE | 0.3MG | TABLET;ORAL | Prescription | Yes | AB | 017407 | BOEHRINGER INGELHEIM |
| CLONIDINE HYDROCHLORIDE | CLONIDINE HYDROCHLORIDE | 0.3MG | TABLET;ORAL | Prescription | No | AB | 070976 | ACTAVIS ELIZABETH |
| CLONIDINE HYDROCHLORIDE | CLONIDINE HYDROCHLORIDE | 0.3MG | TABLET;ORAL | Prescription | No | AB | 091368 | ALEMBIC PHARMS LTD |
| CLONIDINE HYDROCHLORIDE | CLONIDINE HYDROCHLORIDE | 0.3MG | TABLET;ORAL | Prescription | No | AB | 070923 | FRONTIDA BIOPHARM |
| CLONIDINE HYDROCHLORIDE | CLONIDINE HYDROCHLORIDE | 0.3MG | TABLET;ORAL | Prescription | No | AB | 078099 | IMPAX LABS |
| CLONIDINE HYDROCHLORIDE | CLONIDINE HYDROCHLORIDE | 0.3MG | TABLET;ORAL | Prescription | No | AB | 077901 | PRINSTON INC |
| CLONIDINE HYDROCHLORIDE | CLONIDINE HYDROCHLORIDE | 0.3MG | TABLET;ORAL | Prescription | No | AB | 078895 | UNICHEM |
| CLONIDINE HYDROCHLORIDE | CLONIDINE HYDROCHLORIDE | 0.3MG | TABLET;ORAL | Prescription | No | AB | 202297 | YUNG SHIN PHARM |
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