Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 078085
Company: HOSPIRA
Company: HOSPIRA
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
METOPROLOL TARTRATE | METOPROLOL TARTRATE | 1MG/ML | INJECTABLE;INJECTION | Prescription | AP | No | 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 |
---|---|---|---|---|---|---|---|
04/29/2008 | 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 |
---|---|---|---|---|---|
10/25/2021 | SUPPL-13 | Labeling-Package Insert |
Label is not available on this site. |
||
10/30/2019 | SUPPL-9 | Labeling-Package Insert |
Label is not available on this site. |
||
08/13/2015 | SUPPL-7 | Labeling-Package Insert |
Label is not available on this site. |
||
02/27/2013 | SUPPL-6 | Labeling-Package Insert |
Label is not available on this site. |
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03/10/2010 | SUPPL-4 | Labeling-Package Insert |
Label is not available on this site. |
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11/04/2008 | SUPPL-2 | Labeling |
Label is not available on this site. |
METOPROLOL TARTRATE
INJECTABLE;INJECTION; 1MG/ML
TE Code = AP
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
METOPROLOL TARTRATE | METOPROLOL TARTRATE | 1MG/ML | INJECTABLE;INJECTION | Prescription | No | AP | 078950 | BAXTER HLTHCARE CORP |
METOPROLOL TARTRATE | METOPROLOL TARTRATE | 1MG/ML | INJECTABLE;INJECTION | Prescription | No | AP | 091045 | FRESENIUS KABI USA |
METOPROLOL TARTRATE | METOPROLOL TARTRATE | 1MG/ML | INJECTABLE;INJECTION | Prescription | No | AP | 204205 | GLAND PHARMA LTD |
METOPROLOL TARTRATE | METOPROLOL TARTRATE | 1MG/ML | INJECTABLE;INJECTION | Prescription | No | AP | 076495 | HIKMA |
METOPROLOL TARTRATE | METOPROLOL TARTRATE | 1MG/ML | INJECTABLE;INJECTION | Prescription | No | AP | 077761 | HIKMA FARMACEUTICA |
METOPROLOL TARTRATE | METOPROLOL TARTRATE | 1MG/ML | INJECTABLE;INJECTION | Prescription | No | AP | 078085 | HOSPIRA |
METOPROLOL TARTRATE | METOPROLOL TARTRATE | 1MG/ML | INJECTABLE;INJECTION | Prescription | No | AP | 077360 | SANDOZ |