Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 077171
Company: PH HEALTH
Company: PH HEALTH
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| CLONAZEPAM | CLONAZEPAM | 0.125MG | TABLET, ORALLY DISINTEGRATING;ORAL | Prescription | AB | No | No |
| CLONAZEPAM | CLONAZEPAM | 0.25MG | TABLET, ORALLY DISINTEGRATING;ORAL | Prescription | AB | No | No |
| CLONAZEPAM | CLONAZEPAM | 0.5MG | TABLET, ORALLY DISINTEGRATING;ORAL | Prescription | AB | No | No |
| CLONAZEPAM | CLONAZEPAM | 1MG | TABLET, ORALLY DISINTEGRATING;ORAL | Prescription | AB | No | Yes |
| CLONAZEPAM | CLONAZEPAM | 2MG | TABLET, ORALLY DISINTEGRATING;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 |
|---|---|---|---|---|---|---|---|
| 08/03/2005 | ORIG-1 | Approval |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/077171ltr.pdf |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 01/17/2023 | SUPPL-19 | Labeling-Package Insert |
Label is not available on this site. |
||
| 02/05/2021 | SUPPL-17 | Labeling-Package Insert |
Label is not available on this site. |
||
| 01/22/2021 | SUPPL-13 | Labeling-Package Insert |
Label is not available on this site. |
||
| 12/16/2016 | SUPPL-11 | Labeling-Package Insert |
Label is not available on this site. |
||
| 07/26/2013 | SUPPL-8 | Labeling, REMS-Proposal |
Label is not available on this site. |
||
| 12/07/2009 | SUPPL-6 | Labeling |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/077171s006ltr.pdf |
CLONAZEPAM
TABLET, ORALLY DISINTEGRATING;ORAL; 0.125MG
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| CLONAZEPAM | CLONAZEPAM | 0.125MG | TABLET, ORALLY DISINTEGRATING;ORAL | Prescription | No | AB | 211033 | ALEMBIC |
| CLONAZEPAM | CLONAZEPAM | 0.125MG | TABLET, ORALLY DISINTEGRATING;ORAL | Prescription | No | AB | 077194 | BARR |
| CLONAZEPAM | CLONAZEPAM | 0.125MG | TABLET, ORALLY DISINTEGRATING;ORAL | Prescription | No | AB | 077171 | PH HEALTH |
| CLONAZEPAM | CLONAZEPAM | 0.125MG | TABLET, ORALLY DISINTEGRATING;ORAL | Prescription | No | AB | 216988 | RUBICON RESEARCH |
TABLET, ORALLY DISINTEGRATING;ORAL; 0.25MG
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| CLONAZEPAM | CLONAZEPAM | 0.25MG | TABLET, ORALLY DISINTEGRATING;ORAL | Prescription | No | AB | 211033 | ALEMBIC |
| CLONAZEPAM | CLONAZEPAM | 0.25MG | TABLET, ORALLY DISINTEGRATING;ORAL | Prescription | No | AB | 077194 | BARR |
| CLONAZEPAM | CLONAZEPAM | 0.25MG | TABLET, ORALLY DISINTEGRATING;ORAL | Prescription | No | AB | 077171 | PH HEALTH |
| CLONAZEPAM | CLONAZEPAM | 0.25MG | TABLET, ORALLY DISINTEGRATING;ORAL | Prescription | No | AB | 216988 | RUBICON RESEARCH |
TABLET, ORALLY DISINTEGRATING;ORAL; 0.5MG
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| CLONAZEPAM | CLONAZEPAM | 0.5MG | TABLET, ORALLY DISINTEGRATING;ORAL | Prescription | No | AB | 211033 | ALEMBIC |
| CLONAZEPAM | CLONAZEPAM | 0.5MG | TABLET, ORALLY DISINTEGRATING;ORAL | Prescription | No | AB | 077194 | BARR |
| CLONAZEPAM | CLONAZEPAM | 0.5MG | TABLET, ORALLY DISINTEGRATING;ORAL | Prescription | No | AB | 077171 | PH HEALTH |
| CLONAZEPAM | CLONAZEPAM | 0.5MG | TABLET, ORALLY DISINTEGRATING;ORAL | Prescription | No | AB | 216988 | RUBICON RESEARCH |
TABLET, ORALLY DISINTEGRATING;ORAL; 1MG
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| CLONAZEPAM | CLONAZEPAM | 1MG | TABLET, ORALLY DISINTEGRATING;ORAL | Prescription | No | AB | 211033 | ALEMBIC |
| CLONAZEPAM | CLONAZEPAM | 1MG | TABLET, ORALLY DISINTEGRATING;ORAL | Prescription | No | AB | 077194 | BARR |
| CLONAZEPAM | CLONAZEPAM | 1MG | TABLET, ORALLY DISINTEGRATING;ORAL | Prescription | No | AB | 077171 | PH HEALTH |
| CLONAZEPAM | CLONAZEPAM | 1MG | TABLET, ORALLY DISINTEGRATING;ORAL | Prescription | No | AB | 216988 | RUBICON RESEARCH |
TABLET, ORALLY DISINTEGRATING;ORAL; 2MG
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| CLONAZEPAM | CLONAZEPAM | 2MG | TABLET, ORALLY DISINTEGRATING;ORAL | Prescription | No | AB | 211033 | ALEMBIC |
| CLONAZEPAM | CLONAZEPAM | 2MG | TABLET, ORALLY DISINTEGRATING;ORAL | Prescription | No | AB | 077194 | BARR |
| CLONAZEPAM | CLONAZEPAM | 2MG | TABLET, ORALLY DISINTEGRATING;ORAL | Prescription | No | AB | 077171 | PH HEALTH |
| CLONAZEPAM | CLONAZEPAM | 2MG | TABLET, ORALLY DISINTEGRATING;ORAL | Prescription | No | AB | 216988 | RUBICON RESEARCH |