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 FRONTIDA BIOPHARM
Abbreviated New Drug Application (ANDA): 070923
Company: FRONTIDA BIOPHARM
| 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 |
| CLONIDINE HYDROCHLORIDE | CLONIDINE HYDROCHLORIDE | 0.2MG | TABLET;ORAL | Prescription |
AB |
No | No |
| CLONIDINE HYDROCHLORIDE | CLONIDINE HYDROCHLORIDE | 0.1MG | 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 |
|---|---|---|---|---|---|---|---|
| 09/04/1987 | 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 |
|---|---|---|---|---|---|
| 01/17/2013 | SUPPL-31 | Labeling-Package Insert |
Label is not available on this site. |
||
| 05/10/2010 | SUPPL-30 | Labeling-Package Insert |
Label is not available on this site. |
||
| 03/11/2010 | SUPPL-29 | Labeling-Package Insert |
Label is not available on this site. |
||
| 10/06/2005 | SUPPL-19 | Labeling |
Label is not available on this site. |
||
| 12/01/1998 | SUPPL-15 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 06/23/1997 | SUPPL-14 | Labeling |
Label is not available on this site. |
||
| 12/23/1994 | SUPPL-13 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 10/11/1994 | SUPPL-12 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/03/1992 | SUPPL-11 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/03/1992 | SUPPL-9 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 08/03/1989 | SUPPL-8 | Labeling |
Label is not available on this site. |
||
| 04/21/1989 | SUPPL-6 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/21/1989 | SUPPL-5 | Labeling |
Label is not available on this site. |
||
| 09/28/1988 | SUPPL-4 | Labeling |
Label is not available on this site. |
||
| 01/20/1988 | 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 |
TABLET;ORAL; 0.2MG
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| CATAPRES | CLONIDINE HYDROCHLORIDE | 0.2MG | TABLET;ORAL | Prescription | Yes | AB | 017407 | BOEHRINGER INGELHEIM |
| CLONIDINE HYDROCHLORIDE | CLONIDINE HYDROCHLORIDE | 0.2MG | TABLET;ORAL | Prescription | No | AB | 070975 | ACTAVIS ELIZABETH |
| CLONIDINE HYDROCHLORIDE | CLONIDINE HYDROCHLORIDE | 0.2MG | TABLET;ORAL | Prescription | No | AB | 091368 | ALEMBIC PHARMS LTD |
| CLONIDINE HYDROCHLORIDE | CLONIDINE HYDROCHLORIDE | 0.2MG | TABLET;ORAL | Prescription | No | AB | 070923 | FRONTIDA BIOPHARM |
| CLONIDINE HYDROCHLORIDE | CLONIDINE HYDROCHLORIDE | 0.2MG | TABLET;ORAL | Prescription | No | AB | 078099 | IMPAX LABS |
| CLONIDINE HYDROCHLORIDE | CLONIDINE HYDROCHLORIDE | 0.2MG | TABLET;ORAL | Prescription | No | AB | 077901 | PRINSTON INC |
| CLONIDINE HYDROCHLORIDE | CLONIDINE HYDROCHLORIDE | 0.2MG | TABLET;ORAL | Prescription | No | AB | 078895 | UNICHEM |
| CLONIDINE HYDROCHLORIDE | CLONIDINE HYDROCHLORIDE | 0.2MG | TABLET;ORAL | Prescription | No | AB | 202297 | YUNG SHIN PHARM |
TABLET;ORAL; 0.1MG
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| CATAPRES | CLONIDINE HYDROCHLORIDE | 0.1MG | TABLET;ORAL | Prescription | Yes | AB | 017407 | BOEHRINGER INGELHEIM |
| CLONIDINE HYDROCHLORIDE | CLONIDINE HYDROCHLORIDE | 0.1MG | TABLET;ORAL | Prescription | No | AB | 070974 | ACTAVIS ELIZABETH |
| CLONIDINE HYDROCHLORIDE | CLONIDINE HYDROCHLORIDE | 0.1MG | TABLET;ORAL | Prescription | No | AB | 091368 | ALEMBIC PHARMS LTD |
| CLONIDINE HYDROCHLORIDE | CLONIDINE HYDROCHLORIDE | 0.1MG | TABLET;ORAL | Prescription | No | AB | 070923 | FRONTIDA BIOPHARM |
| CLONIDINE HYDROCHLORIDE | CLONIDINE HYDROCHLORIDE | 0.1MG | TABLET;ORAL | Prescription | No | AB | 078099 | IMPAX LABS |
| CLONIDINE HYDROCHLORIDE | CLONIDINE HYDROCHLORIDE | 0.1MG | TABLET;ORAL | Prescription | No | AB | 077901 | PRINSTON INC |
| CLONIDINE HYDROCHLORIDE | CLONIDINE HYDROCHLORIDE | 0.1MG | TABLET;ORAL | Prescription | No | AB | 078895 | UNICHEM |
| CLONIDINE HYDROCHLORIDE | CLONIDINE HYDROCHLORIDE | 0.1MG | TABLET;ORAL | Prescription | No | AB | 202297 | YUNG SHIN PHARM |
منبع : www.accessdata.fda.gov
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