Drugs@FDA: FDA-Approved Drugs
Company: HOSPIRA
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
DOPAMINE HYDROCHLORIDE | DOPAMINE HYDROCHLORIDE | 40MG/ML | INJECTABLE;INJECTION | Prescription | AP | Yes | Yes |
DOPAMINE HYDROCHLORIDE | DOPAMINE HYDROCHLORIDE | 80MG/100ML | INJECTABLE;INJECTION | Prescription | AP | Yes | Yes |
DOPAMINE HYDROCHLORIDE | DOPAMINE HYDROCHLORIDE | 160MG/100ML | INJECTABLE;INJECTION | Prescription | AP | Yes | Yes |
DOPAMINE HYDROCHLORIDE | DOPAMINE HYDROCHLORIDE | 80MG/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 |
---|---|---|---|---|---|---|---|
05/19/1981 | ORIG-1 | Approval |
Label is not available on this site. |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
09/12/2023 | SUPPL-71 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/018132Orig1s071lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/018132Orig1s071ltr.pdf | |
05/14/2014 | SUPPL-67 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/018132s067,018826s045lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/018132Orig1s067,018826Orig1s045ltr.pdf | |
07/02/2008 | SUPPL-59 | Labeling |
Label is not available on this site. |
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10/25/2002 | SUPPL-51 | Manufacturing (CMC)-Microbiology-Processing |
Label is not available on this site. |
||
03/22/2001 | SUPPL-50 | Manufacturing (CMC)-Microbiology-Processing |
Label is not available on this site. |
||
03/22/2001 | SUPPL-49 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
01/07/2000 | SUPPL-48 | Labeling |
Label is not available on this site. |
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01/07/2000 | SUPPL-47 | Manufacturing (CMC)-Microbiology-Processing |
Label is not available on this site. |
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12/09/1998 | SUPPL-46 | Manufacturing (CMC) |
Label is not available on this site. |
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10/03/1996 | SUPPL-45 | Manufacturing (CMC)-Microbiology-Processing |
Label is not available on this site. |
||
10/22/1996 | SUPPL-43 | Manufacturing (CMC)-Microbiology-Processing |
Label is not available on this site. |
||
11/02/1995 | SUPPL-41 | Manufacturing (CMC) |
Label is not available on this site. |
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09/20/1996 | SUPPL-40 | Manufacturing (CMC)-Microbiology-Processing |
Label is not available on this site. |
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07/15/1994 | SUPPL-39 | Manufacturing (CMC) |
Label is not available on this site. |
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02/24/1994 | SUPPL-38 | Manufacturing (CMC) |
Label is not available on this site. |
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01/12/1993 | SUPPL-37 | Labeling |
Label is not available on this site. |
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01/31/1992 | SUPPL-36 | Labeling |
Label is not available on this site. |
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06/14/1991 | SUPPL-35 | Labeling |
Label is not available on this site. |
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07/02/1991 | SUPPL-34 | Manufacturing (CMC) |
Label is not available on this site. |
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07/02/1991 | SUPPL-33 | Manufacturing (CMC) |
Label is not available on this site. |
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08/03/1990 | SUPPL-32 | Manufacturing (CMC) |
Label is not available on this site. |
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08/24/1989 | SUPPL-30 | Labeling |
Label is not available on this site. |
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11/29/1988 | SUPPL-29 | Labeling |
Label is not available on this site. |
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03/07/1988 | SUPPL-28 | Labeling |
Label is not available on this site. |
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09/22/1987 | SUPPL-27 | Labeling |
Label is not available on this site. |
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07/20/1987 | SUPPL-26 | Manufacturing (CMC) |
Label is not available on this site. |
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09/10/1984 | SUPPL-25 | 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 |
---|---|---|---|---|---|
09/12/2023 | SUPPL-71 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/018132Orig1s071lbl.pdf | |
05/14/2014 | SUPPL-67 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/018132s067,018826s045lbl.pdf |
DOPAMINE HYDROCHLORIDE
INJECTABLE;INJECTION; 40MG/ML
TE Code = AP
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
DOPAMINE HYDROCHLORIDE | DOPAMINE HYDROCHLORIDE | 40MG/ML | INJECTABLE;INJECTION | Prescription | No | AP | 207707 | HIKMA INTL PHARMS |
DOPAMINE HYDROCHLORIDE | DOPAMINE HYDROCHLORIDE | 40MG/ML | INJECTABLE;INJECTION | Prescription | Yes | AP | 018132 | HOSPIRA |
INJECTABLE;INJECTION; 80MG/100ML
TE Code = AP
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
DOPAMINE HYDROCHLORIDE | DOPAMINE HYDROCHLORIDE | 80MG/100ML | INJECTABLE;INJECTION | Prescription | Yes | AP | 018132 | HOSPIRA |
DOPAMINE HYDROCHLORIDE IN DEXTROSE 5% IN PLASTIC CONTAINER | DOPAMINE HYDROCHLORIDE | 80MG/100ML | INJECTABLE;INJECTION | Prescription | Yes | AP | 019615 | BAXTER HLTHCARE |
DOPAMINE HYDROCHLORIDE IN DEXTROSE 5% IN PLASTIC CONTAINER | DOPAMINE HYDROCHLORIDE | 80MG/100ML | INJECTABLE;INJECTION | Prescription | Yes | AP | 018826 | HOSPIRA |
INJECTABLE;INJECTION; 160MG/100ML
TE Code = AP
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
DOPAMINE HYDROCHLORIDE | DOPAMINE HYDROCHLORIDE | 160MG/100ML | INJECTABLE;INJECTION | Prescription | Yes | AP | 018132 | HOSPIRA |
DOPAMINE HYDROCHLORIDE IN DEXTROSE 5% IN PLASTIC CONTAINER | DOPAMINE HYDROCHLORIDE | 160MG/100ML | INJECTABLE;INJECTION | Prescription | Yes | AP | 019615 | BAXTER HLTHCARE |
DOPAMINE HYDROCHLORIDE IN DEXTROSE 5% IN PLASTIC CONTAINER | DOPAMINE HYDROCHLORIDE | 160MG/100ML | INJECTABLE;INJECTION | Prescription | Yes | AP | 018826 | HOSPIRA |
INJECTABLE;INJECTION; 80MG/ML
TE Code = AP
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
DOPAMINE HYDROCHLORIDE | DOPAMINE HYDROCHLORIDE | 80MG/ML | INJECTABLE;INJECTION | Prescription | No | AP | 207707 | HIKMA INTL PHARMS |
DOPAMINE HYDROCHLORIDE | DOPAMINE HYDROCHLORIDE | 80MG/ML | INJECTABLE;INJECTION | Prescription | Yes | AP | 018132 | HOSPIRA |