Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 217000
Company: BIONPHARMA
Company: BIONPHARMA
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
DOXYLAMINE SUCCINATE AND PYRIDOXINE HYDROCHLORIDE | DOXYLAMINE SUCCINATE; PYRIDOXINE HYDROCHLORIDE | 10MG;10MG | TABLET, DELAYED RELEASE;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 |
---|---|---|---|---|---|---|---|
08/04/2023 | ORIG-1 | Approval | STANDARD |
Label is not available on this site. |
DOXYLAMINE SUCCINATE AND PYRIDOXINE HYDROCHLORIDE
TABLET, DELAYED RELEASE;ORAL; 10MG;10MG
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
DICLEGIS | DOXYLAMINE SUCCINATE; PYRIDOXINE HYDROCHLORIDE | 10MG;10MG | TABLET, DELAYED RELEASE;ORAL | Prescription | Yes | AB | 021876 | DUCHESNAY |
DOXYLAMINE SUCCINATE AND PYRIDOXINE HYDROCHLORIDE | DOXYLAMINE SUCCINATE; PYRIDOXINE HYDROCHLORIDE | 10MG;10MG | TABLET, DELAYED RELEASE;ORAL | Prescription | No | AB | 205811 | ACTAVIS LABS FL INC |
DOXYLAMINE SUCCINATE AND PYRIDOXINE HYDROCHLORIDE | DOXYLAMINE SUCCINATE; PYRIDOXINE HYDROCHLORIDE | 10MG;10MG | TABLET, DELAYED RELEASE;ORAL | Prescription | No | AB | 217000 | BIONPHARMA |
DOXYLAMINE SUCCINATE AND PYRIDOXINE HYDROCHLORIDE | DOXYLAMINE SUCCINATE; PYRIDOXINE HYDROCHLORIDE | 10MG;10MG | TABLET, DELAYED RELEASE;ORAL | Prescription | No | AB | 207825 | MYLAN PHARMS INC |
DOXYLAMINE SUCCINATE AND PYRIDOXINE HYDROCHLORIDE | DOXYLAMINE SUCCINATE; PYRIDOXINE HYDROCHLORIDE | 10MG;10MG | TABLET, DELAYED RELEASE;ORAL | Prescription | No | AB | 208518 | PAR PHARM INC |