Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 204522
Company: PAR PHARM INC
Company: PAR PHARM INC
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| PHENOXYBENZAMINE HYDROCHLORIDE | PHENOXYBENZAMINE HYDROCHLORIDE | 10MG | CAPSULE;ORAL | Prescription | AB | No | Yes |
Original Approvals or Tentative Approvals
| Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
|---|---|---|---|---|---|---|---|
| 01/24/2017 | ORIG-1 | Approval |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/204522Orig1s000ltr.pdf |
PHENOXYBENZAMINE HYDROCHLORIDE
CAPSULE;ORAL; 10MG
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| DIBENZYLINE | PHENOXYBENZAMINE HYDROCHLORIDE | 10MG | CAPSULE;ORAL | Prescription | Yes | AB | 008708 | CONCORDIA |
| PHENOXYBENZAMINE HYDROCHLORIDE | PHENOXYBENZAMINE HYDROCHLORIDE | 10MG | CAPSULE;ORAL | Prescription | No | AB | 212568 | AMNEAL |
| PHENOXYBENZAMINE HYDROCHLORIDE | PHENOXYBENZAMINE HYDROCHLORIDE | 10MG | CAPSULE;ORAL | Prescription | No | AB | 215600 | AUROBINDO PHARMA |
| PHENOXYBENZAMINE HYDROCHLORIDE | PHENOXYBENZAMINE HYDROCHLORIDE | 10MG | CAPSULE;ORAL | Prescription | No | AB | 201050 | HIKMA |
| PHENOXYBENZAMINE HYDROCHLORIDE | PHENOXYBENZAMINE HYDROCHLORIDE | 10MG | CAPSULE;ORAL | Prescription | No | AB | 215042 | NOVITIUM PHARMA |
| PHENOXYBENZAMINE HYDROCHLORIDE | PHENOXYBENZAMINE HYDROCHLORIDE | 10MG | CAPSULE;ORAL | Prescription | No | AB | 204522 | PAR PHARM INC |
| PHENOXYBENZAMINE HYDROCHLORIDE | PHENOXYBENZAMINE HYDROCHLORIDE | 10MG | CAPSULE;ORAL | Prescription | No | AB | 204551 | RISING |