Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 019893
Company: ICU MEDICAL INC
Company: ICU MEDICAL INC
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| DEXTROSE 70% IN PLASTIC CONTAINER | DEXTROSE | 70GM/100ML | INJECTABLE;INJECTION | Prescription | AP | Yes | Yes |
Original Approvals or Tentative Approvals
| Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
|---|---|---|---|---|---|---|---|
| 12/26/1989 | ORIG-1 | Approval | Type 5 - New Formulation or New Manufacturer | 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 |
|---|---|---|---|---|---|
| 12/18/2003 | SUPPL-16 | Labeling |
Label is not available on this site. |
||
| 11/01/2002 | SUPPL-14 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 07/16/1999 | SUPPL-13 | Labeling |
Label is not available on this site. |
||
| 05/19/1999 | SUPPL-12 | Labeling |
Label is not available on this site. |
||
| 01/05/1999 | SUPPL-11 | Labeling |
Label is not available on this site. |
||
| 08/22/1997 | SUPPL-10 | Labeling |
Label is not available on this site. |
||
| 08/18/1995 | SUPPL-9 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 08/14/1995 | SUPPL-8 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 08/27/1996 | SUPPL-7 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 12/13/1993 | SUPPL-6 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 01/21/1993 | SUPPL-4 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 01/28/1992 | SUPPL-3 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 09/10/1991 | SUPPL-2 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 07/31/1990 | SUPPL-1 | Manufacturing (CMC) |
Label is not available on this site. |
DEXTROSE 70% IN PLASTIC CONTAINER
INJECTABLE;INJECTION; 70GM/100ML
TE Code = AP
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| DEXTROSE 70% IN PLASTIC CONTAINER | DEXTROSE | 70GM/100ML | INJECTABLE;INJECTION | Prescription | Yes | AP | 019626 | B BRAUN |
| DEXTROSE 70% IN PLASTIC CONTAINER | DEXTROSE | 70GM/100ML | INJECTABLE;INJECTION | Prescription | Yes | AP | 020047 | BAXTER HLTHCARE |
| DEXTROSE 70% IN PLASTIC CONTAINER | DEXTROSE | 70GM/100ML | INJECTABLE;INJECTION | Prescription | Yes | AP | 018561 | ICU MEDICAL INC |
| DEXTROSE 70% IN PLASTIC CONTAINER | DEXTROSE | 70GM/100ML | INJECTABLE;INJECTION | Prescription | Yes | AP | 019893 | ICU MEDICAL INC |