Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 090585
Company: SAGENT PHARMS
Company: SAGENT PHARMS
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
ORPHENADRINE CITRATE | ORPHENADRINE CITRATE | 30MG/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 |
---|---|---|---|---|---|---|---|
08/30/2011 | ORIG-1 | Approval |
Label is not available on this site. |
ORPHENADRINE CITRATE
INJECTABLE;INJECTION; 30MG/ML
TE Code = AP
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
ORPHENADRINE CITRATE | ORPHENADRINE CITRATE | 30MG/ML | INJECTABLE;INJECTION | Prescription | No | AP | 040463 | HIKMA |
ORPHENADRINE CITRATE | ORPHENADRINE CITRATE | 30MG/ML | INJECTABLE;INJECTION | Prescription | No | AP | 040484 | RISING PHARMA |
ORPHENADRINE CITRATE | ORPHENADRINE CITRATE | 30MG/ML | INJECTABLE;INJECTION | Prescription | No | AP | 090585 | SAGENT PHARMS |
ORPHENADRINE CITRATE | ORPHENADRINE CITRATE | 30MG/ML | INJECTABLE;INJECTION | Prescription | No | AP | 084779 | WATSON LABS |