Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 204205
Company: GLAND PHARMA LTD
Company: GLAND PHARMA LTD
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 |
---|---|---|---|---|---|---|---|
08/27/2014 | 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 |
---|---|---|---|---|---|
11/16/2021 | SUPPL-4 | Labeling-Package Insert |
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 |