Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 074569
Company: TEVA
Company: TEVA
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| CLONAZEPAM | CLONAZEPAM | 0.5MG | TABLET;ORAL | Prescription | AB | No | No |
| CLONAZEPAM | CLONAZEPAM | 1MG | TABLET;ORAL | Prescription | AB | No | No |
| CLONAZEPAM | CLONAZEPAM | 2MG | 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 |
|---|---|---|---|---|---|---|---|
| 09/10/1996 | 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 |
|---|---|---|---|---|---|
| 07/18/2016 | SUPPL-41 | Labeling-Package Insert |
Label is not available on this site. |
||
| 07/19/2012 | SUPPL-40 | REMS-Proposal |
Label is not available on this site. |
||
| 04/08/2011 | SUPPL-38 | REMS-Proposal |
Label is not available on this site. |
||
| 04/08/2011 | SUPPL-37 | Labeling-Container/Carton Labels, Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
||
| 10/15/2009 | SUPPL-33 | Labeling |
Label is not available on this site. |
||
| 10/15/2009 | SUPPL-32 | Labeling |
Label is not available on this site. |
||
| 05/07/2009 | SUPPL-31 | Labeling |
Label is not available on this site. |
||
| 10/16/2001 | SUPPL-19 | Labeling |
Label is not available on this site. |
||
| 10/13/2000 | SUPPL-18 | Labeling |
Label is not available on this site. |
||
| 12/02/1999 | SUPPL-17 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
||
| 12/02/1999 | SUPPL-16 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
||
| 02/12/1999 | SUPPL-10 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 02/12/1999 | SUPPL-9 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 10/08/1998 | SUPPL-8 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 06/22/1998 | SUPPL-7 | Labeling |
Label is not available on this site. |
||
| 06/22/1998 | SUPPL-6 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 06/22/1998 | SUPPL-5 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 02/18/1998 | SUPPL-4 | Labeling |
Label is not available on this site. |
||
| 11/25/1997 | SUPPL-3 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 07/16/1997 | SUPPL-2 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 01/28/1998 | SUPPL-1 | Manufacturing (CMC) |
Label is not available on this site. |
CLONAZEPAM
TABLET;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;ORAL | Prescription | No | AB | 077147 | ACCORD HLTHCARE |
| CLONAZEPAM | CLONAZEPAM | 0.5MG | TABLET;ORAL | Prescription | No | AB | 074869 | ACTAVIS ELIZABETH |
| CLONAZEPAM | CLONAZEPAM | 0.5MG | TABLET;ORAL | Prescription | No | AB | 075150 | AUROBINDO PHARMA USA |
| CLONAZEPAM | CLONAZEPAM | 0.5MG | TABLET;ORAL | Prescription | No | AB | 077856 | PRINSTON INC |
| CLONAZEPAM | CLONAZEPAM | 0.5MG | TABLET;ORAL | Prescription | No | AB | 075468 | RUBICON |
| CLONAZEPAM | CLONAZEPAM | 0.5MG | TABLET;ORAL | Prescription | No | AB | 074979 | SANDOZ |
| CLONAZEPAM | CLONAZEPAM | 0.5MG | TABLET;ORAL | Prescription | No | AB | 074569 | TEVA |
| KLONOPIN | CLONAZEPAM | 0.5MG | TABLET;ORAL | Prescription | Yes | AB | 017533 | CHEPLAPHARM |
TABLET;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;ORAL | Prescription | No | AB | 077147 | ACCORD HLTHCARE |
| CLONAZEPAM | CLONAZEPAM | 1MG | TABLET;ORAL | Prescription | No | AB | 074869 | ACTAVIS ELIZABETH |
| CLONAZEPAM | CLONAZEPAM | 1MG | TABLET;ORAL | Prescription | No | AB | 075150 | AUROBINDO PHARMA USA |
| CLONAZEPAM | CLONAZEPAM | 1MG | TABLET;ORAL | Prescription | No | AB | 077856 | PRINSTON INC |
| CLONAZEPAM | CLONAZEPAM | 1MG | TABLET;ORAL | Prescription | No | AB | 075468 | RUBICON |
| CLONAZEPAM | CLONAZEPAM | 1MG | TABLET;ORAL | Prescription | No | AB | 074979 | SANDOZ |
| CLONAZEPAM | CLONAZEPAM | 1MG | TABLET;ORAL | Prescription | No | AB | 074569 | TEVA |
| KLONOPIN | CLONAZEPAM | 1MG | TABLET;ORAL | Prescription | Yes | AB | 017533 | CHEPLAPHARM |
TABLET;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;ORAL | Prescription | No | AB | 077147 | ACCORD HLTHCARE |
| CLONAZEPAM | CLONAZEPAM | 2MG | TABLET;ORAL | Prescription | No | AB | 074869 | ACTAVIS ELIZABETH |
| CLONAZEPAM | CLONAZEPAM | 2MG | TABLET;ORAL | Prescription | No | AB | 075150 | AUROBINDO PHARMA USA |
| CLONAZEPAM | CLONAZEPAM | 2MG | TABLET;ORAL | Prescription | No | AB | 077856 | PRINSTON INC |
| CLONAZEPAM | CLONAZEPAM | 2MG | TABLET;ORAL | Prescription | No | AB | 075468 | RUBICON |
| CLONAZEPAM | CLONAZEPAM | 2MG | TABLET;ORAL | Prescription | No | AB | 074979 | SANDOZ |
| CLONAZEPAM | CLONAZEPAM | 2MG | TABLET;ORAL | Prescription | No | AB | 074569 | TEVA |
| KLONOPIN | CLONAZEPAM | 2MG | TABLET;ORAL | Prescription | Yes | AB | 017533 | CHEPLAPHARM |