Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 077901
Company: PRINSTON INC
Company: PRINSTON INC
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
CLONIDINE HYDROCHLORIDE | CLONIDINE HYDROCHLORIDE | 0.1MG | TABLET;ORAL | Prescription | AB | No | No |
CLONIDINE HYDROCHLORIDE | CLONIDINE HYDROCHLORIDE | 0.2MG | TABLET;ORAL | Prescription | AB | No | No |
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 |
---|---|---|---|---|---|---|---|
03/09/2007 | 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 |
---|---|---|---|---|---|
07/13/2015 | SUPPL-5 | Labeling-Package Insert |
Label is not available on this site. |
||
05/27/2010 | SUPPL-2 | Labeling-Package Insert |
Label is not available on this site. |
CLONIDINE HYDROCHLORIDE
TABLET;ORAL; 0.1MG
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
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 | 070886 | AUROBINDO PHARMA LTD |
CLONIDINE HYDROCHLORIDE | CLONIDINE HYDROCHLORIDE | 0.1MG | TABLET;ORAL | Prescription | No | AB | 071785 | CHARTWELL MOLECULES |
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 | 070923 | URL LABS |
CLONIDINE HYDROCHLORIDE | CLONIDINE HYDROCHLORIDE | 0.1MG | 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 |
---|---|---|---|---|---|---|---|---|
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 | 070886 | AUROBINDO PHARMA LTD |
CLONIDINE HYDROCHLORIDE | CLONIDINE HYDROCHLORIDE | 0.2MG | TABLET;ORAL | Prescription | No | AB | 071785 | CHARTWELL MOLECULES |
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 | 070923 | URL LABS |
CLONIDINE HYDROCHLORIDE | CLONIDINE HYDROCHLORIDE | 0.2MG | TABLET;ORAL | Prescription | No | AB | 202297 | YUNG SHIN PHARM |
TABLET;ORAL; 0.3MG
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
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 | 070886 | AUROBINDO PHARMA LTD |
CLONIDINE HYDROCHLORIDE | CLONIDINE HYDROCHLORIDE | 0.3MG | TABLET;ORAL | Prescription | No | AB | 071785 | CHARTWELL MOLECULES |
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 | 070923 | URL LABS |
CLONIDINE HYDROCHLORIDE | CLONIDINE HYDROCHLORIDE | 0.3MG | TABLET;ORAL | Prescription | No | AB | 202297 | YUNG SHIN PHARM |