Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 007513
Company: HOSPIRA
Company: HOSPIRA
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
LEVOPHED | NOREPINEPHRINE BITARTRATE | EQ 1MG BASE/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 |
---|---|---|---|---|---|---|---|
07/13/1950 | ORIG-1 | Approval | Type 1 - New Molecular Entity | PRIORITY |
Label is not available on this site. |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
10/21/2020 | SUPPL-45 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/007513s045lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/007513Orig1s045ltr.pdf | |
06/15/2020 | SUPPL-38 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) Review (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/007513s038lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/007513Orig1s038ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2024/007513Orig1s038.pdf | |
09/26/2007 | SUPPL-24 | Labeling-Container/Carton Labels, Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/007513Orig1s024lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/007513s024ltr.pdf | |
09/20/1999 | SUPPL-22 | Labeling |
Label is not available on this site. |
||
09/13/1991 | SUPPL-21 | Labeling |
Label is not available on this site. |
||
06/12/1991 | SUPPL-20 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
03/02/1988 | SUPPL-19 | Labeling |
Label is not available on this site. |
||
05/27/1987 | SUPPL-18 | Labeling |
Label is not available on this site. |
||
01/14/1985 | SUPPL-17 | Labeling |
Label is not available on this site. |
||
04/06/1989 | SUPPL-16 | Labeling |
Label is not available on this site. |
||
04/14/1978 | SUPPL-15 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
02/14/1977 | SUPPL-9 | Unspecified |
Label is not available on this site. |
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
---|---|---|---|---|---|
10/21/2020 | SUPPL-45 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/007513s045lbl.pdf | |
06/15/2020 | SUPPL-38 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/007513s038lbl.pdf | |
09/26/2007 | SUPPL-24 | Labeling-Container/Carton Labels | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/007513Orig1s024lbl.pdf | |
09/26/2007 | SUPPL-24 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/007513Orig1s024lbl.pdf |
LEVOPHED
INJECTABLE;INJECTION; EQ 1MG BASE/ML
TE Code = AP
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
LEVOPHED | NOREPINEPHRINE BITARTRATE | EQ 1MG BASE/ML | INJECTABLE;INJECTION | Prescription | Yes | AP | 007513 | HOSPIRA |
NOREPINEPHRINE BITARTRATE | NOREPINEPHRINE BITARTRATE | EQ 1MG BASE/ML | INJECTABLE;INJECTION | Prescription | No | AP | 210839 | AMNEAL |
NOREPINEPHRINE BITARTRATE | NOREPINEPHRINE BITARTRATE | EQ 1MG BASE/ML | INJECTABLE;INJECTION | Prescription | No | AP | 219163 | ASPIRO |
NOREPINEPHRINE BITARTRATE | NOREPINEPHRINE BITARTRATE | EQ 1MG BASE/ML | INJECTABLE;INJECTION | Prescription | No | AP | 040859 | BAXTER HLTHCARE CORP |
NOREPINEPHRINE BITARTRATE | NOREPINEPHRINE BITARTRATE | EQ 1MG BASE/ML | INJECTABLE;INJECTION | Prescription | No | AP | 214455 | BRECKENRIDGE |
NOREPINEPHRINE BITARTRATE | NOREPINEPHRINE BITARTRATE | EQ 1MG BASE/ML | INJECTABLE;INJECTION | Prescription | No | AP | 217575 | CAPLIN |
NOREPINEPHRINE BITARTRATE | NOREPINEPHRINE BITARTRATE | EQ 1MG BASE/ML | INJECTABLE;INJECTION | Prescription | No | AP | 211382 | FRESENIUS KABI USA |
NOREPINEPHRINE BITARTRATE | NOREPINEPHRINE BITARTRATE | EQ 1MG BASE/ML | INJECTABLE;INJECTION | Prescription | No | AP | 214323 | GLAND PHARMA LTD |
NOREPINEPHRINE BITARTRATE | NOREPINEPHRINE BITARTRATE | EQ 1MG BASE/ML | INJECTABLE;INJECTION | Prescription | No | AP | 040462 | HIKMA |
NOREPINEPHRINE BITARTRATE | NOREPINEPHRINE BITARTRATE | EQ 1MG BASE/ML | INJECTABLE;INJECTION | Prescription | No | AP | 203662 | HIKMA |
NOREPINEPHRINE BITARTRATE | NOREPINEPHRINE BITARTRATE | EQ 1MG BASE/ML | INJECTABLE;INJECTION | Prescription | No | AP | 040455 | MEITHEAL |
NOREPINEPHRINE BITARTRATE | NOREPINEPHRINE BITARTRATE | EQ 1MG BASE/ML | INJECTABLE;INJECTION | Prescription | No | AP | 211242 | MYLAN LABS LTD |
NOREPINEPHRINE BITARTRATE | NOREPINEPHRINE BITARTRATE | EQ 1MG BASE/ML | INJECTABLE;INJECTION | Prescription | No | AP | 218758 | RISING |
NOREPINEPHRINE BITARTRATE | NOREPINEPHRINE BITARTRATE | EQ 1MG BASE/ML | INJECTABLE;INJECTION | Prescription | No | AP | 211359 | SANDOZ |