Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 089686
Company: SANDOZ
Company: SANDOZ
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| PERPHENAZINE | PERPHENAZINE | 16MG | TABLET;ORAL | Prescription | AB | Yes | 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 |
|---|---|---|---|---|---|---|---|
| 12/08/1988 | ORIG-1 | Approval |
Label is not available on this site. |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 12/06/2010 | SUPPL-23 | Labeling-Package Insert |
Label (PDF)
|
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/089683s024lbl.pdf | |
| 05/27/2009 | SUPPL-22 | Labeling |
Label is not available on this site. |
||
| 11/25/2008 | SUPPL-21 | Labeling |
Label is not available on this site. |
||
| 11/19/2008 | SUPPL-20 | Labeling |
Label is not available on this site. |
||
| 05/29/2008 | SUPPL-14 | Labeling |
Label is not available on this site. |
||
| 10/22/2002 | SUPPL-13 | Labeling |
Label is not available on this site. |
||
| 09/26/2002 | SUPPL-12 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 10/22/2002 | SUPPL-11 | Labeling |
Label is not available on this site. |
||
| 05/15/2001 | SUPPL-10 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 02/27/2001 | SUPPL-9 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 05/05/1999 | SUPPL-7 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 09/15/1998 | SUPPL-6 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 10/16/1998 | SUPPL-5 | Labeling |
Label is not available on this site. |
||
| 10/16/1998 | SUPPL-4 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 03/02/1995 | SUPPL-3 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 03/26/1991 | SUPPL-2 | Labeling |
Label is not available on this site. |
||
| 10/01/1990 | SUPPL-1 | Labeling |
Label is not available on this site. |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 12/06/2010 | SUPPL-23 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/089683s024lbl.pdf |
PERPHENAZINE
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 | 040226 | ENDO OPERATIONS |
| PERPHENAZINE | PERPHENAZINE | 16MG | TABLET;ORAL | Prescription | No | AB | 212545 | MACLEODS PHARMS LTD |
| 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 |