Drugs@FDA: FDA-Approved Drugs
Company: ACTAVIS TOTOWA
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| DESIPRAMINE HYDROCHLORIDE | DESIPRAMINE HYDROCHLORIDE | 75MG | 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 |
|---|---|---|---|---|---|---|---|
| 10/05/1987 | 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 |
|---|---|---|---|---|---|
| 09/06/2024 | SUPPL-32 | Labeling-Package Insert, Labeling-Container/Carton Labels, Labeling-Medication Guide |
Label is not available on this site. |
||
| 01/21/2020 | SUPPL-29 | Labeling-Package Insert, Labeling-Medication Guide |
Label is not available on this site. |
||
| 01/05/2015 | SUPPL-27 | Labeling-Package Insert |
Label is not available on this site. |
||
| 03/25/2010 | SUPPL-23 | Labeling-Package Insert |
Label is not available on this site. |
||
| 11/28/2007 | SUPPL-21 | Labeling |
Label is not available on this site. |
||
| 11/28/2007 | SUPPL-20 | Labeling |
Label is not available on this site. |
||
| 05/19/2006 | SUPPL-19 | Labeling |
Label is not available on this site. |
||
| 08/04/2005 | SUPPL-18 | Labeling |
Label is not available on this site. |
||
| 02/02/2000 | SUPPL-16 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
||
| 12/27/1996 | SUPPL-15 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 12/27/1996 | SUPPL-14 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/05/1995 | SUPPL-13 | Labeling |
Label is not available on this site. |
||
| 05/30/1995 | SUPPL-12 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 05/30/1995 | SUPPL-9 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 08/18/1993 | SUPPL-8 | Labeling |
Label is not available on this site. |
||
| 07/09/1992 | SUPPL-7 | Labeling |
Label is not available on this site. |
||
| 06/24/1992 | SUPPL-6 | Labeling |
Label is not available on this site. |
||
| 02/12/1992 | SUPPL-5 | Labeling |
Label is not available on this site. |
||
| 03/29/1990 | SUPPL-4 | Bioequivalence |
Label is not available on this site. |
||
| 01/09/1995 | SUPPL-2 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 03/31/1989 | SUPPL-1 | Manufacturing (CMC) |
Label is not available on this site. |
DESIPRAMINE HYDROCHLORIDE
TABLET;ORAL; 75MG
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| DESIPRAMINE HYDROCHLORIDE | DESIPRAMINE HYDROCHLORIDE | 75MG | TABLET;ORAL | Prescription | No | AB | 071602 | ACTAVIS TOTOWA |
| DESIPRAMINE HYDROCHLORIDE | DESIPRAMINE HYDROCHLORIDE | 75MG | TABLET;ORAL | Prescription | No | AB | 209785 | ALEMBIC |
| DESIPRAMINE HYDROCHLORIDE | DESIPRAMINE HYDROCHLORIDE | 75MG | TABLET;ORAL | Prescription | No | AB | 208105 | AMNEAL PHARMS CO |
| DESIPRAMINE HYDROCHLORIDE | DESIPRAMINE HYDROCHLORIDE | 75MG | TABLET;ORAL | Prescription | No | AB | 072103 | CHARTWELL RX |
| DESIPRAMINE HYDROCHLORIDE | DESIPRAMINE HYDROCHLORIDE | 75MG | TABLET;ORAL | Prescription | No | AB | 207433 | HERITAGE |
| DESIPRAMINE HYDROCHLORIDE | DESIPRAMINE HYDROCHLORIDE | 75MG | TABLET;ORAL | Prescription | No | AB | 204963 | NOVAST LABS |
| NORPRAMIN | DESIPRAMINE HYDROCHLORIDE | 75MG | TABLET;ORAL | Prescription | Yes | AB | 014399 | VALIDUS PHARMS |