Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 216649
Company: APOTEX
Company: APOTEX
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| FLUPHENAZINE HYDROCHLORIDE | FLUPHENAZINE HYDROCHLORIDE | 1MG | TABLET;ORAL | Prescription | AB | No | No |
| FLUPHENAZINE HYDROCHLORIDE | FLUPHENAZINE HYDROCHLORIDE | 2.5MG | TABLET;ORAL | Prescription | AB | No | No |
| FLUPHENAZINE HYDROCHLORIDE | FLUPHENAZINE HYDROCHLORIDE | 5MG | TABLET;ORAL | Prescription | AB | No | No |
| FLUPHENAZINE HYDROCHLORIDE | FLUPHENAZINE HYDROCHLORIDE | 10MG | TABLET;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 |
|---|---|---|---|---|---|---|---|
| 07/15/2022 | ORIG-1 | Approval | STANDARD |
Label is not available on this site. |
FLUPHENAZINE HYDROCHLORIDE
TABLET;ORAL; 1MG
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| FLUPHENAZINE HYDROCHLORIDE | FLUPHENAZINE HYDROCHLORIDE | 1MG | TABLET;ORAL | Prescription | No | AB | 217410 | AJANTA PHARMA LTD |
| FLUPHENAZINE HYDROCHLORIDE | FLUPHENAZINE HYDROCHLORIDE | 1MG | TABLET;ORAL | Prescription | No | AB | 213647 | AMNEAL |
| FLUPHENAZINE HYDROCHLORIDE | FLUPHENAZINE HYDROCHLORIDE | 1MG | TABLET;ORAL | Prescription | No | AB | 216649 | APOTEX |
| FLUPHENAZINE HYDROCHLORIDE | FLUPHENAZINE HYDROCHLORIDE | 1MG | TABLET;ORAL | Prescription | No | AB | 218055 | AUROBINDO PHARMA LTD |
| FLUPHENAZINE HYDROCHLORIDE | FLUPHENAZINE HYDROCHLORIDE | 1MG | TABLET;ORAL | Prescription | No | AB | 214534 | DR REDDYS |
| FLUPHENAZINE HYDROCHLORIDE | FLUPHENAZINE HYDROCHLORIDE | 1MG | TABLET;ORAL | Prescription | No | AB | 216350 | GLENMARK PHARMS LTD |
| FLUPHENAZINE HYDROCHLORIDE | FLUPHENAZINE HYDROCHLORIDE | 1MG | TABLET;ORAL | Prescription | No | AB | 089740 | LANNETT |
| FLUPHENAZINE HYDROCHLORIDE | FLUPHENAZINE HYDROCHLORIDE | 1MG | TABLET;ORAL | Prescription | No | AB | 089743 | LANNETT CO INC |
| FLUPHENAZINE HYDROCHLORIDE | FLUPHENAZINE HYDROCHLORIDE | 1MG | TABLET;ORAL | Prescription | No | AB | 217189 | MSN |
| FLUPHENAZINE HYDROCHLORIDE | FLUPHENAZINE HYDROCHLORIDE | 1MG | TABLET;ORAL | Prescription | No | AB | 214674 | NOVITIUM PHARMA |
| FLUPHENAZINE HYDROCHLORIDE | FLUPHENAZINE HYDROCHLORIDE | 1MG | TABLET;ORAL | Prescription | No | AB | 216891 | SANDOZ |
| FLUPHENAZINE HYDROCHLORIDE | FLUPHENAZINE HYDROCHLORIDE | 1MG | TABLET;ORAL | Prescription | No | AB | 215674 | TARO |
| FLUPHENAZINE HYDROCHLORIDE | FLUPHENAZINE HYDROCHLORIDE | 1MG | TABLET;ORAL | Prescription | No | AB | 215848 | TWI PHARMS |
| FLUPHENAZINE HYDROCHLORIDE | FLUPHENAZINE HYDROCHLORIDE | 1MG | TABLET;ORAL | Prescription | No | AB | 213784 | UPSHER SMITH LABS |
| FLUPHENAZINE HYDROCHLORIDE | FLUPHENAZINE HYDROCHLORIDE | 1MG | TABLET;ORAL | Prescription | No | AB | 215141 | ZAMEER PHARMS |
| FLUPHENAZINE HYDROCHLORIDE | FLUPHENAZINE HYDROCHLORIDE | 1MG | TABLET;ORAL | Prescription | No | AB | 214552 | ZYDUS LIFESCIENCES |
TABLET;ORAL; 2.5MG
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| FLUPHENAZINE HYDROCHLORIDE | FLUPHENAZINE HYDROCHLORIDE | 2.5MG | TABLET;ORAL | Prescription | No | AB | 217410 | AJANTA PHARMA LTD |
| FLUPHENAZINE HYDROCHLORIDE | FLUPHENAZINE HYDROCHLORIDE | 2.5MG | TABLET;ORAL | Prescription | No | AB | 213647 | AMNEAL |
| FLUPHENAZINE HYDROCHLORIDE | FLUPHENAZINE HYDROCHLORIDE | 2.5MG | TABLET;ORAL | Prescription | No | AB | 216649 | APOTEX |
| FLUPHENAZINE HYDROCHLORIDE | FLUPHENAZINE HYDROCHLORIDE | 2.5MG | TABLET;ORAL | Prescription | No | AB | 218055 | AUROBINDO PHARMA LTD |
| FLUPHENAZINE HYDROCHLORIDE | FLUPHENAZINE HYDROCHLORIDE | 2.5MG | TABLET;ORAL | Prescription | No | AB | 214534 | DR REDDYS |
| FLUPHENAZINE HYDROCHLORIDE | FLUPHENAZINE HYDROCHLORIDE | 2.5MG | TABLET;ORAL | Prescription | No | AB | 216350 | GLENMARK PHARMS LTD |
| FLUPHENAZINE HYDROCHLORIDE | FLUPHENAZINE HYDROCHLORIDE | 2.5MG | TABLET;ORAL | Prescription | No | AB | 089741 | LANNETT |
| FLUPHENAZINE HYDROCHLORIDE | FLUPHENAZINE HYDROCHLORIDE | 2.5MG | TABLET;ORAL | Prescription | No | AB | 089743 | LANNETT CO INC |
| FLUPHENAZINE HYDROCHLORIDE | FLUPHENAZINE HYDROCHLORIDE | 2.5MG | TABLET;ORAL | Prescription | No | AB | 217189 | MSN |
| FLUPHENAZINE HYDROCHLORIDE | FLUPHENAZINE HYDROCHLORIDE | 2.5MG | TABLET;ORAL | Prescription | No | AB | 214674 | NOVITIUM PHARMA |
| FLUPHENAZINE HYDROCHLORIDE | FLUPHENAZINE HYDROCHLORIDE | 2.5MG | TABLET;ORAL | Prescription | No | AB | 216891 | SANDOZ |
| FLUPHENAZINE HYDROCHLORIDE | FLUPHENAZINE HYDROCHLORIDE | 2.5MG | TABLET;ORAL | Prescription | No | AB | 215674 | TARO |
| FLUPHENAZINE HYDROCHLORIDE | FLUPHENAZINE HYDROCHLORIDE | 2.5MG | TABLET;ORAL | Prescription | No | AB | 215848 | TWI PHARMS |
| FLUPHENAZINE HYDROCHLORIDE | FLUPHENAZINE HYDROCHLORIDE | 2.5MG | TABLET;ORAL | Prescription | No | AB | 213784 | UPSHER SMITH LABS |
| FLUPHENAZINE HYDROCHLORIDE | FLUPHENAZINE HYDROCHLORIDE | 2.5MG | TABLET;ORAL | Prescription | No | AB | 215141 | ZAMEER PHARMS |
| FLUPHENAZINE HYDROCHLORIDE | FLUPHENAZINE HYDROCHLORIDE | 2.5MG | TABLET;ORAL | Prescription | No | AB | 214552 | ZYDUS LIFESCIENCES |
TABLET;ORAL; 5MG
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| FLUPHENAZINE HYDROCHLORIDE | FLUPHENAZINE HYDROCHLORIDE | 5MG | TABLET;ORAL | Prescription | No | AB | 217410 | AJANTA PHARMA LTD |
| FLUPHENAZINE HYDROCHLORIDE | FLUPHENAZINE HYDROCHLORIDE | 5MG | TABLET;ORAL | Prescription | No | AB | 213647 | AMNEAL |
| FLUPHENAZINE HYDROCHLORIDE | FLUPHENAZINE HYDROCHLORIDE | 5MG | TABLET;ORAL | Prescription | No | AB | 216649 | APOTEX |
| FLUPHENAZINE HYDROCHLORIDE | FLUPHENAZINE HYDROCHLORIDE | 5MG | TABLET;ORAL | Prescription | No | AB | 218055 | AUROBINDO PHARMA LTD |
| FLUPHENAZINE HYDROCHLORIDE | FLUPHENAZINE HYDROCHLORIDE | 5MG | TABLET;ORAL | Prescription | No | AB | 214534 | DR REDDYS |
| FLUPHENAZINE HYDROCHLORIDE | FLUPHENAZINE HYDROCHLORIDE | 5MG | TABLET;ORAL | Prescription | No | AB | 216350 | GLENMARK PHARMS LTD |
| FLUPHENAZINE HYDROCHLORIDE | FLUPHENAZINE HYDROCHLORIDE | 5MG | TABLET;ORAL | Prescription | No | AB | 089742 | LANNETT |
| FLUPHENAZINE HYDROCHLORIDE | FLUPHENAZINE HYDROCHLORIDE | 5MG | TABLET;ORAL | Prescription | No | AB | 089743 | LANNETT CO INC |
| FLUPHENAZINE HYDROCHLORIDE | FLUPHENAZINE HYDROCHLORIDE | 5MG | TABLET;ORAL | Prescription | No | AB | 217189 | MSN |
| FLUPHENAZINE HYDROCHLORIDE | FLUPHENAZINE HYDROCHLORIDE | 5MG | TABLET;ORAL | Prescription | No | AB | 214674 | NOVITIUM PHARMA |
| FLUPHENAZINE HYDROCHLORIDE | FLUPHENAZINE HYDROCHLORIDE | 5MG | TABLET;ORAL | Prescription | No | AB | 089585 | SANDOZ |
| FLUPHENAZINE HYDROCHLORIDE | FLUPHENAZINE HYDROCHLORIDE | 5MG | TABLET;ORAL | Prescription | No | AB | 216891 | SANDOZ |
| FLUPHENAZINE HYDROCHLORIDE | FLUPHENAZINE HYDROCHLORIDE | 5MG | TABLET;ORAL | Prescription | No | AB | 215674 | TARO |
| FLUPHENAZINE HYDROCHLORIDE | FLUPHENAZINE HYDROCHLORIDE | 5MG | TABLET;ORAL | Prescription | No | AB | 215848 | TWI PHARMS |
| FLUPHENAZINE HYDROCHLORIDE | FLUPHENAZINE HYDROCHLORIDE | 5MG | TABLET;ORAL | Prescription | No | AB | 213784 | UPSHER SMITH LABS |
| FLUPHENAZINE HYDROCHLORIDE | FLUPHENAZINE HYDROCHLORIDE | 5MG | TABLET;ORAL | Prescription | No | AB | 215141 | ZAMEER PHARMS |
| FLUPHENAZINE HYDROCHLORIDE | FLUPHENAZINE HYDROCHLORIDE | 5MG | TABLET;ORAL | Prescription | No | AB | 214552 | ZYDUS LIFESCIENCES |
TABLET;ORAL; 10MG
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| FLUPHENAZINE HYDROCHLORIDE | FLUPHENAZINE HYDROCHLORIDE | 10MG | TABLET;ORAL | Prescription | No | AB | 217410 | AJANTA PHARMA LTD |
| FLUPHENAZINE HYDROCHLORIDE | FLUPHENAZINE HYDROCHLORIDE | 10MG | TABLET;ORAL | Prescription | No | AB | 213647 | AMNEAL |
| FLUPHENAZINE HYDROCHLORIDE | FLUPHENAZINE HYDROCHLORIDE | 10MG | TABLET;ORAL | Prescription | No | AB | 216649 | APOTEX |
| FLUPHENAZINE HYDROCHLORIDE | FLUPHENAZINE HYDROCHLORIDE | 10MG | TABLET;ORAL | Prescription | No | AB | 218055 | AUROBINDO PHARMA LTD |
| FLUPHENAZINE HYDROCHLORIDE | FLUPHENAZINE HYDROCHLORIDE | 10MG | TABLET;ORAL | Prescription | No | AB | 214534 | DR REDDYS |
| FLUPHENAZINE HYDROCHLORIDE | FLUPHENAZINE HYDROCHLORIDE | 10MG | TABLET;ORAL | Prescription | No | AB | 216350 | GLENMARK PHARMS LTD |
| FLUPHENAZINE HYDROCHLORIDE | FLUPHENAZINE HYDROCHLORIDE | 10MG | TABLET;ORAL | Prescription | No | AB | 089743 | LANNETT CO INC |
| FLUPHENAZINE HYDROCHLORIDE | FLUPHENAZINE HYDROCHLORIDE | 10MG | TABLET;ORAL | Prescription | No | AB | 217189 | MSN |
| FLUPHENAZINE HYDROCHLORIDE | FLUPHENAZINE HYDROCHLORIDE | 10MG | TABLET;ORAL | Prescription | No | AB | 214674 | NOVITIUM PHARMA |
| FLUPHENAZINE HYDROCHLORIDE | FLUPHENAZINE HYDROCHLORIDE | 10MG | TABLET;ORAL | Prescription | No | AB | 216891 | SANDOZ |
| FLUPHENAZINE HYDROCHLORIDE | FLUPHENAZINE HYDROCHLORIDE | 10MG | TABLET;ORAL | Prescription | No | AB | 215674 | TARO |
| FLUPHENAZINE HYDROCHLORIDE | FLUPHENAZINE HYDROCHLORIDE | 10MG | TABLET;ORAL | Prescription | No | AB | 215848 | TWI PHARMS |
| FLUPHENAZINE HYDROCHLORIDE | FLUPHENAZINE HYDROCHLORIDE | 10MG | TABLET;ORAL | Prescription | No | AB | 213784 | UPSHER SMITH LABS |
| FLUPHENAZINE HYDROCHLORIDE | FLUPHENAZINE HYDROCHLORIDE | 10MG | TABLET;ORAL | Prescription | No | AB | 215141 | ZAMEER PHARMS |
| FLUPHENAZINE HYDROCHLORIDE | FLUPHENAZINE HYDROCHLORIDE | 10MG | TABLET;ORAL | Prescription | No | AB | 214552 | ZYDUS LIFESCIENCES |