Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 020179
Company: BAXTER HLTHCARE
Company: BAXTER HLTHCARE
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 |
---|---|---|---|---|---|---|---|
12/07/1992 | 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 |
---|---|---|---|---|---|
08/05/2019 | SUPPL-56 |
Label (PDF)
|
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/020179s056lbl.pdf | ||
12/07/2022 | SUPPL-26 | Labeling-Package Insert |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/020178Orig1s031ltr;020179Orig1s026ltr.pdf |
08/05/2019 | SUPPL-12 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/016673s149,016694s121,017521s069,020047s021,020179s012lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/016673Orig1s149, 016694Orig1s121, 020047Orig1s021, 020179Orig1s012ltr.pdf | |
11/20/2003 | SUPPL-7 | Labeling |
Label is not available on this site. |
||
05/04/2001 | SUPPL-5 | Manufacturing (CMC)-Microbiology-Processing |
Label is not available on this site. |
||
12/29/1997 | SUPPL-4 | Manufacturing (CMC) |
Label is not available on this site. |
||
09/15/1999 | SUPPL-3 | Labeling |
Label is not available on this site. |
||
02/18/1994 | SUPPL-2 | Manufacturing (CMC) |
Label is not available on this site. |
||
09/30/1994 | SUPPL-1 | Manufacturing (CMC) |
Label is not available on this site. |
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
---|---|---|---|---|---|
08/05/2019 | SUPPL-56 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/020179s056lbl.pdf | |
08/05/2019 | SUPPL-12 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/016673s149,016694s121,017521s069,020047s021,020179s012lbl.pdf |
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 |