Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 205232
Company: ZYDUS PHARMS
Company: ZYDUS PHARMS
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| PERPHENAZINE | PERPHENAZINE | 2MG | TABLET;ORAL | Prescription | AB | No | No |
| PERPHENAZINE | PERPHENAZINE | 4MG | TABLET;ORAL | Prescription | AB | No | No |
| PERPHENAZINE | PERPHENAZINE | 8MG | TABLET;ORAL | Prescription | AB | No | No |
| PERPHENAZINE | PERPHENAZINE | 16MG | 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 |
|---|---|---|---|---|---|---|---|
| 04/06/2020 | ORIG-1 | Approval | STANDARD |
Label is not available on this site. |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 05/01/2026 | SUPPL-3 | Labeling-Package Insert |
Label is not available on this site. |
||
| 01/22/2025 | SUPPL-2 | Labeling-Package Insert |
Label is not available on this site. |
PERPHENAZINE
TABLET;ORAL; 2MG
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| PERPHENAZINE | PERPHENAZINE | 2MG | TABLET;ORAL | Prescription | No | AB | 210163 | APPCO |
| PERPHENAZINE | PERPHENAZINE | 2MG | TABLET;ORAL | Prescription | No | AB | 213694 | JUBILANT GENERICS |
| PERPHENAZINE | PERPHENAZINE | 2MG | TABLET;ORAL | Prescription | No | AB | 212545 | MACLEODS PHARMS LTD |
| PERPHENAZINE | PERPHENAZINE | 2MG | TABLET;ORAL | Prescription | No | AB | 040226 | PH HEALTH |
| PERPHENAZINE | PERPHENAZINE | 2MG | TABLET;ORAL | Prescription | No | AB | 205056 | RISING |
| PERPHENAZINE | PERPHENAZINE | 2MG | TABLET;ORAL | Prescription | No | AB | 089683 | SANDOZ |
| PERPHENAZINE | PERPHENAZINE | 2MG | TABLET;ORAL | Prescription | No | AB | 089685 | SANDOZ |
| PERPHENAZINE | PERPHENAZINE | 2MG | TABLET;ORAL | Prescription | No | AB | 207582 | WATSON LABS INC |
| PERPHENAZINE | PERPHENAZINE | 2MG | TABLET;ORAL | Prescription | No | AB | 205973 | WILSHIRE PHARMS INC |
| PERPHENAZINE | PERPHENAZINE | 2MG | TABLET;ORAL | Prescription | No | AB | 205232 | ZYDUS PHARMS |
TABLET;ORAL; 4MG
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| PERPHENAZINE | PERPHENAZINE | 4MG | TABLET;ORAL | Prescription | No | AB | 210163 | APPCO |
| PERPHENAZINE | PERPHENAZINE | 4MG | TABLET;ORAL | Prescription | No | AB | 213694 | JUBILANT GENERICS |
| PERPHENAZINE | PERPHENAZINE | 4MG | TABLET;ORAL | Prescription | No | AB | 212545 | MACLEODS PHARMS LTD |
| PERPHENAZINE | PERPHENAZINE | 4MG | TABLET;ORAL | Prescription | No | AB | 040226 | PH HEALTH |
| PERPHENAZINE | PERPHENAZINE | 4MG | TABLET;ORAL | Prescription | No | AB | 205056 | RISING |
| PERPHENAZINE | PERPHENAZINE | 4MG | TABLET;ORAL | Prescription | No | AB | 089684 | SANDOZ |
| PERPHENAZINE | PERPHENAZINE | 4MG | TABLET;ORAL | Prescription | No | AB | 089685 | SANDOZ |
| PERPHENAZINE | PERPHENAZINE | 4MG | TABLET;ORAL | Prescription | No | AB | 207582 | WATSON LABS INC |
| PERPHENAZINE | PERPHENAZINE | 4MG | TABLET;ORAL | Prescription | No | AB | 205973 | WILSHIRE PHARMS INC |
| PERPHENAZINE | PERPHENAZINE | 4MG | TABLET;ORAL | Prescription | No | AB | 205232 | ZYDUS PHARMS |
TABLET;ORAL; 8MG
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| PERPHENAZINE | PERPHENAZINE | 8MG | TABLET;ORAL | Prescription | No | AB | 210163 | APPCO |
| PERPHENAZINE | PERPHENAZINE | 8MG | TABLET;ORAL | Prescription | No | AB | 213694 | JUBILANT GENERICS |
| PERPHENAZINE | PERPHENAZINE | 8MG | TABLET;ORAL | Prescription | No | AB | 212545 | MACLEODS PHARMS LTD |
| PERPHENAZINE | PERPHENAZINE | 8MG | TABLET;ORAL | Prescription | No | AB | 040226 | PH HEALTH |
| PERPHENAZINE | PERPHENAZINE | 8MG | TABLET;ORAL | Prescription | No | AB | 205056 | RISING |
| PERPHENAZINE | PERPHENAZINE | 8MG | TABLET;ORAL | Prescription | No | AB | 089685 | SANDOZ |
| PERPHENAZINE | PERPHENAZINE | 8MG | TABLET;ORAL | Prescription | No | AB | 207582 | WATSON LABS INC |
| PERPHENAZINE | PERPHENAZINE | 8MG | TABLET;ORAL | Prescription | No | AB | 205973 | WILSHIRE PHARMS INC |
| PERPHENAZINE | PERPHENAZINE | 8MG | TABLET;ORAL | Prescription | No | AB | 205232 | ZYDUS PHARMS |
TABLET;ORAL; 16MG
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| PERPHENAZINE | PERPHENAZINE | 16MG | TABLET;ORAL | Prescription | No | AB | 210163 | APPCO |
| PERPHENAZINE | PERPHENAZINE | 16MG | TABLET;ORAL | Prescription | No | AB | 213694 | JUBILANT GENERICS |
| PERPHENAZINE | PERPHENAZINE | 16MG | TABLET;ORAL | Prescription | No | AB | 212545 | MACLEODS PHARMS LTD |
| PERPHENAZINE | PERPHENAZINE | 16MG | TABLET;ORAL | Prescription | No | AB | 040226 | PH HEALTH |
| PERPHENAZINE | PERPHENAZINE | 16MG | TABLET;ORAL | Prescription | No | AB | 205056 | RISING |
| PERPHENAZINE | PERPHENAZINE | 16MG | TABLET;ORAL | Prescription | No | AB | 089685 | SANDOZ |
| PERPHENAZINE | PERPHENAZINE | 16MG | TABLET;ORAL | Prescription | Yes | AB | 089686 | SANDOZ |
| PERPHENAZINE | PERPHENAZINE | 16MG | TABLET;ORAL | Prescription | No | AB | 207582 | WATSON LABS INC |
| PERPHENAZINE | PERPHENAZINE | 16MG | TABLET;ORAL | Prescription | No | AB | 205973 | WILSHIRE PHARMS INC |
| PERPHENAZINE | PERPHENAZINE | 16MG | TABLET;ORAL | Prescription | No | AB | 205232 | ZYDUS PHARMS |