Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 215548
Company: MISEMER
Company: MISEMER
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
FENOPROFEN CALCIUM | FENOPROFEN CALCIUM | EQ 200MG BASE | CAPSULE;ORAL | Prescription | AB | No | No |
FENOPROFEN CALCIUM | FENOPROFEN CALCIUM | EQ 300MG BASE | CAPSULE;ORAL | Prescription | None | No | No |
FENOPROFEN CALCIUM | FENOPROFEN CALCIUM | EQ 400MG BASE | CAPSULE;ORAL | Prescription | AB | 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 |
---|---|---|---|---|---|---|---|
05/16/2023 | ORIG-1 | Approval | STANDARD |
Label is not available on this site. |
FENOPROFEN CALCIUM
CAPSULE;ORAL; EQ 200MG BASE
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
FENOPROFEN CALCIUM | FENOPROFEN CALCIUM | EQ 200MG BASE | CAPSULE;ORAL | Prescription | No | AB | 215548 | MISEMER |
CAPSULE;ORAL; EQ 400MG BASE
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
FENOPROFEN CALCIUM | FENOPROFEN CALCIUM | EQ 400MG BASE | CAPSULE;ORAL | Prescription | No | AB | 215548 | MISEMER |
FENOPROFEN CALCIUM | FENOPROFEN CALCIUM | EQ 400MG BASE | CAPSULE;ORAL | Prescription | No | AB | 214475 | RISING |