Drugs@FDA: FDA Approved Drug Products
Company: MYLAN
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| PERPHENAZINE AND AMITRIPTYLINE HYDROCHLORIDE | AMITRIPTYLINE HYDROCHLORIDE; PERPHENAZINE | 50MG;4MG | TABLET;ORAL | Prescription | None | No | Yes |
| PERPHENAZINE AND AMITRIPTYLINE HYDROCHLORIDE | AMITRIPTYLINE HYDROCHLORIDE; PERPHENAZINE | 10MG;2MG | TABLET;ORAL | Prescription | None | No | No |
| PERPHENAZINE AND AMITRIPTYLINE HYDROCHLORIDE | AMITRIPTYLINE HYDROCHLORIDE; PERPHENAZINE | 10MG;4MG | TABLET;ORAL | Prescription | None | No | No |
| PERPHENAZINE AND AMITRIPTYLINE HYDROCHLORIDE | AMITRIPTYLINE HYDROCHLORIDE; PERPHENAZINE | 25MG;2MG | TABLET;ORAL | Prescription | None | No | Yes |
| PERPHENAZINE AND AMITRIPTYLINE HYDROCHLORIDE | AMITRIPTYLINE HYDROCHLORIDE; PERPHENAZINE | 25MG;4MG | TABLET;ORAL | Prescription | None | 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 |
|---|---|---|---|---|---|---|---|
| 11/10/1988 | 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 |
|---|---|---|---|---|---|
| 02/23/2017 | SUPPL-32 | Labeling-Package Insert, Labeling-Medication Guide |
Label is not available on this site. |
||
| 04/25/2016 | SUPPL-30 | Labeling-Package Insert |
Label is not available on this site. |
||
| 12/13/2014 | SUPPL-29 | Labeling-Medication Guide |
Label is not available on this site. |
||
| 07/17/2014 | SUPPL-28 | Labeling-Package Insert |
Label (PDF)
|
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/071443s028lbl.pdf | |
| 09/21/2010 | SUPPL-25 | Labeling-Package Insert, Labeling-Container/Carton Labels |
Label is not available on this site. |
||
| 01/21/2009 | SUPPL-24 | Labeling |
Label is not available on this site. |
||
| 10/30/2008 | SUPPL-23 | Labeling |
Label is not available on this site. |
||
| 11/07/2007 | SUPPL-21 | Labeling |
Label is not available on this site. |
||
| 07/11/2007 | SUPPL-20 | Labeling |
Label is not available on this site. |
||
| 07/26/2005 | SUPPL-15 | Labeling |
Label is not available on this site. |
||
| 05/07/2002 | SUPPL-12 | Labeling |
Label is not available on this site. |
||
| 02/25/1998 | SUPPL-11 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 02/05/1998 | SUPPL-10 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 02/04/1997 | SUPPL-9 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 06/28/1995 | SUPPL-8 | Labeling |
Label is not available on this site. |
||
| 10/05/1993 | SUPPL-7 | Labeling |
Label is not available on this site. |
||
| 09/01/1993 | SUPPL-6 | Labeling |
Label is not available on this site. |
||
| 10/22/1993 | SUPPL-5 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 10/05/1993 | SUPPL-3 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 01/31/1990 | SUPPL-2 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 05/01/1989 | 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 |
|---|---|---|---|---|---|
| 07/17/2014 | SUPPL-28 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/071443s028lbl.pdf |
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