Drugs@FDA: FDA-Approved Drugs
Company: B BRAUN
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| DEXTROSE 5% IN PLASTIC CONTAINER | DEXTROSE | 5GM/100ML | INJECTABLE;INJECTION | Prescription | AP | Yes | Yes |
| DEXTROSE 5% IN PLASTIC CONTAINER | DEXTROSE | 50MG/ML | 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 |
|---|---|---|---|---|---|---|---|
| 12/21/1973 | 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 |
|---|---|---|---|---|---|
| 09/29/2014 | SUPPL-52 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 10/19/2006 | SUPPL-50 | Labeling |
Label is not available on this site. |
||
| 08/06/2004 | SUPPL-48 | Labeling |
Label is not available on this site. |
||
| 06/23/1997 | SUPPL-46 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 08/08/1995 | SUPPL-45 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 12/31/1991 | SUPPL-43 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 09/11/1990 | SUPPL-42 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 03/09/1989 | SUPPL-39 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 01/30/1986 | SUPPL-38 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 06/24/1985 | SUPPL-36 | Labeling |
Label is not available on this site. |
||
| 09/16/1985 | SUPPL-35 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 10/16/1984 | SUPPL-34 | Labeling |
Label is not available on this site. |
||
| 10/17/1984 | SUPPL-33 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/03/1985 | SUPPL-32 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/09/1984 | SUPPL-31 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 09/30/1983 | SUPPL-29 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 05/17/1985 | SUPPL-28 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 02/18/1986 | SUPPL-27 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 06/21/1985 | SUPPL-26 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 11/05/1982 | SUPPL-24 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 06/28/1982 | SUPPL-23 | Labeling |
Label is not available on this site. |
||
| 06/28/1982 | SUPPL-22 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 10/26/1981 | SUPPL-21 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 01/24/1983 | SUPPL-20 | Labeling |
Label is not available on this site. |
||
| 09/30/1981 | SUPPL-19 | Labeling |
Label is not available on this site. |
||
| 09/30/1981 | SUPPL-18 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 10/24/1980 | SUPPL-17 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 08/06/1980 | SUPPL-16 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 07/16/1980 | SUPPL-15 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 02/12/1980 | SUPPL-14 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 10/09/1979 | SUPPL-13 | Labeling |
Label is not available on this site. |
||
| 10/16/1979 | SUPPL-12 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 06/08/1979 | SUPPL-11 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 03/14/1979 | SUPPL-10 | Labeling |
Label is not available on this site. |
||
| 10/12/1978 | SUPPL-9 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 03/12/1979 | SUPPL-8 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/28/1978 | SUPPL-7 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 11/02/1978 | SUPPL-6 | Labeling |
Label is not available on this site. |
||
| 11/02/1978 | SUPPL-5 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 10/21/1977 | SUPPL-4 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 08/19/1977 | SUPPL-3 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 05/25/1977 | SUPPL-2 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 12/06/1976 | SUPPL-1 | Labeling |
Label is not available on this site. |
DEXTROSE 5% IN PLASTIC CONTAINER
INJECTABLE;INJECTION; 5GM/100ML
TE Code = AP
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| DEXTROSE 5% IN PLASTIC CONTAINER | DEXTROSE | 5GM/100ML | INJECTABLE;INJECTION | Prescription | Yes | AP | 016730 | B BRAUN |
| DEXTROSE 5% IN PLASTIC CONTAINER | DEXTROSE | 5GM/100ML | INJECTABLE;INJECTION | Prescription | Yes | AP | 019626 | B BRAUN |
| DEXTROSE 5% IN PLASTIC CONTAINER | DEXTROSE | 5GM/100ML | INJECTABLE;INJECTION | Prescription | Yes | AP | 016673 | BAXTER HLTHCARE |
| DEXTROSE 5% IN PLASTIC CONTAINER | DEXTROSE | 5GM/100ML | INJECTABLE;INJECTION | Prescription | Yes | AP | 020179 | BAXTER HLTHCARE |
| DEXTROSE 5% IN PLASTIC CONTAINER | DEXTROSE | 5GM/100ML | INJECTABLE;INJECTION | Prescription | Yes | AP | 019466 | HOSPIRA |
| DEXTROSE 5% IN PLASTIC CONTAINER | DEXTROSE | 5GM/100ML | INJECTABLE;INJECTION | Prescription | Yes | AP | 019479 | HOSPIRA |
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 |