Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 075731
Company: TARO
Company: TARO
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
CLORAZEPATE DIPOTASSIUM | CLORAZEPATE DIPOTASSIUM | 15MG | TABLET;ORAL | Prescription | AB | No | No |
CLORAZEPATE DIPOTASSIUM | CLORAZEPATE DIPOTASSIUM | 7.5MG | TABLET;ORAL | Prescription | AB | No | No |
CLORAZEPATE DIPOTASSIUM | CLORAZEPATE DIPOTASSIUM | 3.75MG | 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 |
---|---|---|---|---|---|---|---|
04/27/2000 | ORIG-1 | Approval |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/75731ltr.pdf |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
03/20/2013 | SUPPL-5 | Labeling-Package Insert |
Label is not available on this site. |
||
09/27/2011 | SUPPL-3 | Labeling-Medication Guide, REMS-Proposal |
Label is not available on this site. |
||
01/20/2010 | SUPPL-2 | Labeling-Package Insert |
Label is not available on this site. |
CLORAZEPATE DIPOTASSIUM
TABLET;ORAL; 15MG
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
CLORAZEPATE DIPOTASSIUM | CLORAZEPATE DIPOTASSIUM | 15MG | TABLET;ORAL | Prescription | No | AB | 071858 | AUROBINDO PHARMA |
CLORAZEPATE DIPOTASSIUM | CLORAZEPATE DIPOTASSIUM | 15MG | TABLET;ORAL | Prescription | No | AB | 215566 | COREPHARMA |
CLORAZEPATE DIPOTASSIUM | CLORAZEPATE DIPOTASSIUM | 15MG | TABLET;ORAL | Prescription | No | AB | 213730 | NOVITIUM PHARMA |
CLORAZEPATE DIPOTASSIUM | CLORAZEPATE DIPOTASSIUM | 15MG | TABLET;ORAL | Prescription | No | AB | 075731 | TARO |
TABLET;ORAL; 7.5MG
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
CLORAZEPATE DIPOTASSIUM | CLORAZEPATE DIPOTASSIUM | 7.5MG | TABLET;ORAL | Prescription | No | AB | 071858 | AUROBINDO PHARMA |
CLORAZEPATE DIPOTASSIUM | CLORAZEPATE DIPOTASSIUM | 7.5MG | TABLET;ORAL | Prescription | No | AB | 215566 | COREPHARMA |
CLORAZEPATE DIPOTASSIUM | CLORAZEPATE DIPOTASSIUM | 7.5MG | TABLET;ORAL | Prescription | No | AB | 213730 | NOVITIUM PHARMA |
CLORAZEPATE DIPOTASSIUM | CLORAZEPATE DIPOTASSIUM | 7.5MG | TABLET;ORAL | Prescription | No | AB | 075731 | TARO |
TRANXENE | CLORAZEPATE DIPOTASSIUM | 7.5MG | TABLET;ORAL | Prescription | Yes | AB | 017105 | AJENAT PHARMS |
TABLET;ORAL; 3.75MG
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
CLORAZEPATE DIPOTASSIUM | CLORAZEPATE DIPOTASSIUM | 3.75MG | TABLET;ORAL | Prescription | No | AB | 071858 | AUROBINDO PHARMA |
CLORAZEPATE DIPOTASSIUM | CLORAZEPATE DIPOTASSIUM | 3.75MG | TABLET;ORAL | Prescription | No | AB | 215566 | COREPHARMA |
CLORAZEPATE DIPOTASSIUM | CLORAZEPATE DIPOTASSIUM | 3.75MG | TABLET;ORAL | Prescription | No | AB | 213730 | NOVITIUM PHARMA |
CLORAZEPATE DIPOTASSIUM | CLORAZEPATE DIPOTASSIUM | 3.75MG | TABLET;ORAL | Prescription | No | AB | 075731 | TARO |