Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 077761
Company: HIKMA FARMACEUTICA
Company: HIKMA FARMACEUTICA
| 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 | 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 |
|---|---|---|---|---|---|---|---|
| 05/30/2007 | 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 |
|---|---|---|---|---|---|
| 03/24/2025 | SUPPL-26 | Labeling-Package Insert |
Label is not available on this site. |
||
| 01/07/2022 | SUPPL-24 | Labeling-Package Insert |
Label is not available on this site. |
||
| 11/12/2015 | SUPPL-16 | Labeling-Package Insert |
Label is not available on this site. |
||
| 02/27/2013 | SUPPL-13 | Labeling-Package Insert |
Label is not available on this site. |
||
| 02/26/2010 | SUPPL-10 | Labeling-Package Insert |
Label is not available on this site. |
||
| 01/19/2010 | SUPPL-9 | Labeling-Package Insert |
Label is not available on this site. |
||
| 02/26/2009 | SUPPL-6 | 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 |
| 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 |