Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 040462
Company: WEST-WARD PHARMS INT
Company: WEST-WARD PHARMS INT
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
NOREPINEPHRINE BITARTRATE | NOREPINEPHRINE BITARTRATE | EQ 1MG BASE/ML | INJECTABLE;INJECTION | Prescription | AP | No | No |
Original Approvals or Tentative Approvals
Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
---|---|---|---|---|---|---|---|
10/31/2003 | ORIG-1 | Approval |
Label is not available on this site. |
NOREPINEPHRINE BITARTRATE
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 | 214455 | ANDERSEN GLOBAL |
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 | 211382 | FRESENIUS KABI USA |
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 | 211242 | MYLAN LABS LTD |
NOREPINEPHRINE BITARTRATE | NOREPINEPHRINE BITARTRATE | EQ 1MG BASE/ML | INJECTABLE;INJECTION | Prescription | No | AP | 211359 | SANDOZ INC |
NOREPINEPHRINE BITARTRATE | NOREPINEPHRINE BITARTRATE | EQ 1MG BASE/ML | INJECTABLE;INJECTION | Prescription | No | AP | 211980 | SUN PHARM |
NOREPINEPHRINE BITARTRATE | NOREPINEPHRINE BITARTRATE | EQ 1MG BASE/ML | INJECTABLE;INJECTION | Prescription | No | AP | 040455 | TEVA PHARMS USA |
NOREPINEPHRINE BITARTRATE | NOREPINEPHRINE BITARTRATE | EQ 1MG BASE/ML | INJECTABLE;INJECTION | Prescription | No | AP | 040462 | WEST-WARD PHARMS INT |
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