Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 207449
Company: FRESENIUS KABI USA
Company: FRESENIUS KABI USA
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| DEXTROSE 5% IN PLASTIC CONTAINER | DEXTROSE | 50MG/ML | INJECTABLE;INJECTION | 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 |
|---|---|---|---|---|---|---|---|
| 10/21/2016 | ORIG-1 | Approval | STANDARD |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/207449Orig1s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/207449Orig1s000ltr.pdf |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 07/20/2022 | SUPPL-19 | Labeling-Package Insert |
Label is not available on this site. |
||
| 11/20/2020 | SUPPL-14 | Labeling-Package Insert |
Label is not available on this site. |
||
| 06/26/2018 | SUPPL-3 | Labeling-Package Insert |
Label is not available on this site. |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 10/21/2016 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/207449Orig1s000lbl.pdf |
DEXTROSE 5% IN PLASTIC CONTAINER
INJECTABLE;INJECTION; 50MG/ML
TE Code = AP
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| DEXTROSE 5% | DEXTROSE | 50MG/ML | INJECTABLE;INJECTION | Prescription | No | AP | 217263 | AM REGENT |
| DEXTROSE 5% IN PLASTIC CONTAINER | DEXTROSE | 50MG/ML | INJECTABLE;INJECTION | Prescription | Yes | AP | 016730 | B BRAUN |
| DEXTROSE 5% IN PLASTIC CONTAINER | DEXTROSE | 50MG/ML | INJECTABLE;INJECTION | Prescription | Yes | AP | 016673 | BAXTER HLTHCARE |
| DEXTROSE 5% IN PLASTIC CONTAINER | DEXTROSE | 50MG/ML | INJECTABLE;INJECTION | Prescription | Yes | AP | 020179 | BAXTER HLTHCARE |
| DEXTROSE 5% IN PLASTIC CONTAINER | DEXTROSE | 50MG/ML | INJECTABLE;INJECTION | Prescription | No | AP | 207449 | FRESENIUS KABI USA |
| DEXTROSE 5% IN PLASTIC CONTAINER | DEXTROSE | 50MG/ML | INJECTABLE;INJECTION | Prescription | Yes | AP | 016367 | ICU MEDICAL INC |