Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 090584
Company: SAGENT PHARMS
Company: SAGENT PHARMS
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| FLUMAZENIL | FLUMAZENIL | 0.5MG/5ML (0.1MG/ML) | INJECTABLE;INJECTION | Prescription | AP | No | No |
| FLUMAZENIL | FLUMAZENIL | 1MG/10ML (0.1MG/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 |
|---|---|---|---|---|---|---|---|
| 08/28/2012 | 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 |
|---|---|---|---|---|---|
| 05/01/2015 | SUPPL-1 | Labeling-Container/Carton Labels |
Label is not available on this site. |
FLUMAZENIL
INJECTABLE;INJECTION; 0.5MG/5ML (0.1MG/ML)
TE Code = AP
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| FLUMAZENIL | FLUMAZENIL | 0.5MG/5ML (0.1MG/ML) | INJECTABLE;INJECTION | Prescription | No | AP | 076755 | BAXTER HLTHCARE CORP |
| FLUMAZENIL | FLUMAZENIL | 0.5MG/5ML (0.1MG/ML) | INJECTABLE;INJECTION | Prescription | No | AP | 076955 | FRESENIUS KABI USA |
| FLUMAZENIL | FLUMAZENIL | 0.5MG/5ML (0.1MG/ML) | INJECTABLE;INJECTION | Prescription | No | AP | 078527 | HIKMA FARMACEUTICA |
| FLUMAZENIL | FLUMAZENIL | 0.5MG/5ML (0.1MG/ML) | INJECTABLE;INJECTION | Prescription | No | AP | 078595 | MYLAN LABS LTD |
| FLUMAZENIL | FLUMAZENIL | 0.5MG/5ML (0.1MG/ML) | INJECTABLE;INJECTION | Prescription | No | AP | 090584 | SAGENT PHARMS |
| FLUMAZENIL | FLUMAZENIL | 0.5MG/5ML (0.1MG/ML) | INJECTABLE;INJECTION | Prescription | No | AP | 077071 | SANDOZ INC |
| FLUMAZENIL | FLUMAZENIL | 0.5MG/5ML (0.1MG/ML) | INJECTABLE;INJECTION | Prescription | No | AP | 076256 | WEST-WARD PHARMS INT |
| FLUMAZENIL | FLUMAZENIL | 0.5MG/5ML (0.1MG/ML) | INJECTABLE;INJECTION | Prescription | No | AP | 076787 | WEST-WARD PHARMS INT |
INJECTABLE;INJECTION; 1MG/10ML (0.1MG/ML)
TE Code = AP
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| FLUMAZENIL | FLUMAZENIL | 1MG/10ML (0.1MG/ML) | INJECTABLE;INJECTION | Prescription | No | AP | 076755 | BAXTER HLTHCARE CORP |
| FLUMAZENIL | FLUMAZENIL | 1MG/10ML (0.1MG/ML) | INJECTABLE;INJECTION | Prescription | No | AP | 076955 | FRESENIUS KABI USA |
| FLUMAZENIL | FLUMAZENIL | 1MG/10ML (0.1MG/ML) | INJECTABLE;INJECTION | Prescription | No | AP | 078527 | HIKMA FARMACEUTICA |
| FLUMAZENIL | FLUMAZENIL | 1MG/10ML (0.1MG/ML) | INJECTABLE;INJECTION | Prescription | No | AP | 090584 | SAGENT PHARMS |
| FLUMAZENIL | FLUMAZENIL | 1MG/10ML (0.1MG/ML) | INJECTABLE;INJECTION | Prescription | No | AP | 077071 | SANDOZ INC |
| FLUMAZENIL | FLUMAZENIL | 1MG/10ML (0.1MG/ML) | INJECTABLE;INJECTION | Prescription | No | AP | 076256 | WEST-WARD PHARMS INT |
| FLUMAZENIL | FLUMAZENIL | 1MG/10ML (0.1MG/ML) | INJECTABLE;INJECTION | Prescription | No | AP | 076787 | WEST-WARD PHARMS INT |
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