Drugs@FDA: FDA-Approved Drugs
Company: BAXTER HLTHCARE
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
DOBUTAMINE HYDROCHLORIDE IN DEXTROSE 5% IN PLASTIC CONTAINER | DOBUTAMINE HYDROCHLORIDE | EQ 50MG BASE/100ML | INJECTABLE;INJECTION | Prescription | AP | Yes | Yes |
DOBUTAMINE HYDROCHLORIDE IN DEXTROSE 5% IN PLASTIC CONTAINER | DOBUTAMINE HYDROCHLORIDE | EQ 100MG BASE/100ML | INJECTABLE;INJECTION | Prescription | AP | Yes | Yes |
DOBUTAMINE HYDROCHLORIDE IN DEXTROSE 5% IN PLASTIC CONTAINER | DOBUTAMINE HYDROCHLORIDE | EQ 200MG BASE/100ML | INJECTABLE;INJECTION | Prescription | AP | Yes | Yes |
DOBUTAMINE HYDROCHLORIDE IN DEXTROSE 5% IN PLASTIC CONTAINER | DOBUTAMINE HYDROCHLORIDE | EQ 400MG BASE/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 |
---|---|---|---|---|---|---|---|
09/27/1993 | 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 |
---|---|---|---|---|---|
09/08/2023 | SUPPL-25 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/020255s025lbledt.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/020255Orig1s025Corrected_ltr.pdf | |
12/10/2020 | SUPPL-22 | Labeling-Container/Carton Labels |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/020255Orig1s022ltr.pdf |
03/27/2019 | SUPPL-20 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/020255s020lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/020255Orig1s020ltr.pdf | |
04/17/2013 | SUPPL-16 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020255s016lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/020255Orig1s016ltr.pdf | |
03/05/2012 | SUPPL-14 | Labeling |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020255s014ltr.pdf |
07/24/2003 | SUPPL-11 | Labeling |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20255slr011,009ltr.pdf |
07/24/2003 | SUPPL-9 | Labeling |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20255slr011,009ltr.pdf |
05/31/2001 | SUPPL-8 | Labeling |
Label is not available on this site. |
||
11/23/1999 | SUPPL-7 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
06/14/2000 | SUPPL-6 | Labeling |
Review (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/20255-s006_dobutamine.pdf |
04/21/1999 | SUPPL-5 | Labeling |
Label is not available on this site. |
||
04/30/1998 | SUPPL-4 | Manufacturing (CMC) |
Label is not available on this site. |
||
03/08/1996 | SUPPL-3 | Manufacturing (CMC) |
Label is not available on this site. |
||
09/29/1994 | SUPPL-2 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
02/16/1994 | SUPPL-1 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
---|---|---|---|---|---|
09/08/2023 | SUPPL-25 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/020255s025lbledt.pdf | |
03/27/2019 | SUPPL-20 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/020255s020lbl.pdf | |
04/17/2013 | SUPPL-16 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020255s016lbl.pdf |
DOBUTAMINE HYDROCHLORIDE IN DEXTROSE 5% IN PLASTIC CONTAINER
INJECTABLE;INJECTION; EQ 50MG BASE/100ML
TE Code = AP
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
DOBUTAMINE HYDROCHLORIDE IN DEXTROSE 5% IN PLASTIC CONTAINER | DOBUTAMINE HYDROCHLORIDE | EQ 50MG BASE/100ML | INJECTABLE;INJECTION | Prescription | Yes | AP | 020255 | BAXTER HLTHCARE |
DOBUTAMINE HYDROCHLORIDE IN DEXTROSE 5% IN PLASTIC CONTAINER | DOBUTAMINE HYDROCHLORIDE | EQ 50MG BASE/100ML | INJECTABLE;INJECTION | Prescription | Yes | AP | 020201 | HOSPIRA |
INJECTABLE;INJECTION; EQ 100MG BASE/100ML
TE Code = AP
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
DOBUTAMINE HYDROCHLORIDE IN DEXTROSE 5% IN PLASTIC CONTAINER | DOBUTAMINE HYDROCHLORIDE | EQ 100MG BASE/100ML | INJECTABLE;INJECTION | Prescription | Yes | AP | 020255 | BAXTER HLTHCARE |
DOBUTAMINE HYDROCHLORIDE IN DEXTROSE 5% IN PLASTIC CONTAINER | DOBUTAMINE HYDROCHLORIDE | EQ 100MG BASE/100ML | INJECTABLE;INJECTION | Prescription | Yes | AP | 020201 | HOSPIRA |
INJECTABLE;INJECTION; EQ 200MG BASE/100ML
TE Code = AP
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
DOBUTAMINE HYDROCHLORIDE IN DEXTROSE 5% IN PLASTIC CONTAINER | DOBUTAMINE HYDROCHLORIDE | EQ 200MG BASE/100ML | INJECTABLE;INJECTION | Prescription | Yes | AP | 020255 | BAXTER HLTHCARE |
DOBUTAMINE HYDROCHLORIDE IN DEXTROSE 5% IN PLASTIC CONTAINER | DOBUTAMINE HYDROCHLORIDE | EQ 200MG BASE/100ML | INJECTABLE;INJECTION | Prescription | Yes | AP | 020201 | HOSPIRA |
INJECTABLE;INJECTION; EQ 400MG BASE/100ML
TE Code = AP
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
DOBUTAMINE HYDROCHLORIDE IN DEXTROSE 5% IN PLASTIC CONTAINER | DOBUTAMINE HYDROCHLORIDE | EQ 400MG BASE/100ML | INJECTABLE;INJECTION | Prescription | Yes | AP | 020255 | BAXTER HLTHCARE |
DOBUTAMINE HYDROCHLORIDE IN DEXTROSE 5% IN PLASTIC CONTAINER | DOBUTAMINE HYDROCHLORIDE | EQ 400MG BASE/100ML | INJECTABLE;INJECTION | Prescription | Yes | AP | 020201 | HOSPIRA |