Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 211033
Company: ALEMBIC
Company: ALEMBIC
| 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 | No |
| 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 |
|---|---|---|---|---|---|---|---|
| 06/28/2019 | ORIG-1 | Approval | STANDARD |
Label is not available on this site. |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 01/17/2023 | SUPPL-11 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
||
| 02/05/2021 | SUPPL-5 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
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 | PAR PHARM |
| CLONAZEPAM | CLONAZEPAM | 0.125MG | TABLET, ORALLY DISINTEGRATING;ORAL | Prescription | No | AB | 078654 | SUN PHARM INDS INC |
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 | PAR PHARM |
| CLONAZEPAM | CLONAZEPAM | 0.25MG | TABLET, ORALLY DISINTEGRATING;ORAL | Prescription | No | AB | 078654 | SUN PHARM INDS INC |
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 | PAR PHARM |
| CLONAZEPAM | CLONAZEPAM | 0.5MG | TABLET, ORALLY DISINTEGRATING;ORAL | Prescription | No | AB | 078654 | SUN PHARM INDS INC |
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 | PAR PHARM |
| CLONAZEPAM | CLONAZEPAM | 1MG | TABLET, ORALLY DISINTEGRATING;ORAL | Prescription | No | AB | 078654 | SUN PHARM INDS INC |
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 | PAR PHARM |
| CLONAZEPAM | CLONAZEPAM | 2MG | TABLET, ORALLY DISINTEGRATING;ORAL | Prescription | No | AB | 078654 | SUN PHARM INDS INC |