Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 204433
Company: CHARTWELL MOLECULAR
Company: CHARTWELL MOLECULAR
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
DIAZEPAM | DIAZEPAM | 5MG/ML | CONCENTRATE;ORAL | Prescription | AA | 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 |
---|---|---|---|---|---|---|---|
04/14/2014 | 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 |
---|---|---|---|---|---|
01/17/2023 | SUPPL-9 | Labeling-Package Insert |
Label is not available on this site. |
||
02/05/2021 | SUPPL-6 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
||
02/04/2021 | SUPPL-3 | Labeling-Package Insert |
Label is not available on this site. |
||
03/24/2016 | SUPPL-2 | Labeling-Package Insert |
Label is not available on this site. |
DIAZEPAM
CONCENTRATE;ORAL; 5MG/ML
TE Code = AA
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
DIAZEPAM | DIAZEPAM | 5MG/ML | CONCENTRATE;ORAL | Prescription | No | AA | 204433 | CHARTWELL MOLECULAR |
DIAZEPAM INTENSOL | DIAZEPAM | 5MG/ML | CONCENTRATE;ORAL | Prescription | No | AA | 071415 | HIKMA |