Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 206477
Company: CHARTWELL MOLECULAR
Company: CHARTWELL MOLECULAR
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
DIAZEPAM | DIAZEPAM | 5MG/5ML | SOLUTION;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 |
---|---|---|---|---|---|---|---|
06/24/2016 | 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-4 | Labeling-Package Insert |
Label is not available on this site. |
||
02/05/2021 | SUPPL-2 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
DIAZEPAM
SOLUTION;ORAL; 5MG/5ML
TE Code = AA
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
DIAZEPAM | DIAZEPAM | 5MG/5ML | SOLUTION;ORAL | Prescription | No | AA | 206477 | CHARTWELL MOLECULAR |
DIAZEPAM | DIAZEPAM | 5MG/5ML | SOLUTION;ORAL | Prescription | No | AA | 070928 | HIKMA |