Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 216159
Company: HIKMA
Company: HIKMA
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| MIDAZOLAM IN 0.9% SODIUM CHLORIDE | MIDAZOLAM | 50MG/50ML (1MG/ML) | SOLUTION;INTRAVENOUS | Prescription | AP | No | No |
| MIDAZOLAM IN 0.9% SODIUM CHLORIDE | MIDAZOLAM | 100MG/100ML (1MG/ML) | SOLUTION;INTRAVENOUS | Prescription | AP | 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 |
|---|---|---|---|---|---|---|---|
| 04/17/2023 | ORIG-1 | Approval | STANDARD |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/216159Orig1s000ltr.pdf |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 06/23/2025 | SUPPL-2 | Labeling-Package Insert |
Label is not available on this site. |
MIDAZOLAM IN 0.9% SODIUM CHLORIDE
SOLUTION;INTRAVENOUS; 50MG/50ML (1MG/ML)
TE Code = AP
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| MIDAZOLAM IN 0.9% SODIUM CHLORIDE | MIDAZOLAM | 50MG/50ML (1MG/ML) | SOLUTION;INTRAVENOUS | Prescription | No | AP | 218993 | GLAND |
| MIDAZOLAM IN 0.9% SODIUM CHLORIDE | MIDAZOLAM | 50MG/50ML (1MG/ML) | SOLUTION;INTRAVENOUS | Prescription | No | AP | 216159 | HIKMA |
| MIDAZOLAM IN 0.9% SODIUM CHLORIDE | MIDAZOLAM | 50MG/50ML (1MG/ML) | SOLUTION;INTRAVENOUS | Prescription | Yes | AP | 211844 | INFORLIFE |
SOLUTION;INTRAVENOUS; 100MG/100ML (1MG/ML)
TE Code = AP
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| MIDAZOLAM IN 0.9% SODIUM CHLORIDE | MIDAZOLAM | 100MG/100ML (1MG/ML) | SOLUTION;INTRAVENOUS | Prescription | No | AP | 218993 | GLAND |
| MIDAZOLAM IN 0.9% SODIUM CHLORIDE | MIDAZOLAM | 100MG/100ML (1MG/ML) | SOLUTION;INTRAVENOUS | Prescription | No | AP | 216159 | HIKMA |
| MIDAZOLAM IN 0.9% SODIUM CHLORIDE | MIDAZOLAM | 100MG/100ML (1MG/ML) | SOLUTION;INTRAVENOUS | Prescription | Yes | AP | 211844 | INFORLIFE |