Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 072102
Company: SANDOZ
Company: SANDOZ
| 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 |
|---|---|---|---|---|---|---|---|
| 06/20/1988 | 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 |
|---|---|---|---|---|---|
| 09/27/2019 | SUPPL-31 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
||
| 03/30/2015 | SUPPL-28 | Labeling-Package Insert |
Label is not available on this site. |
||
| 03/30/2015 | SUPPL-27 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
||
| 03/17/2010 | SUPPL-25 | Labeling-Package Insert |
Label is not available on this site. |
||
| 10/19/2007 | SUPPL-20 | Labeling |
Label is not available on this site. |
||
| 10/19/2007 | SUPPL-17 | Labeling |
Label is not available on this site. |
||
| 07/08/2005 | SUPPL-16 | Labeling |
Label is not available on this site. |
||
| 03/19/2001 | SUPPL-13 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 02/07/2001 | SUPPL-12 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 05/05/1999 | SUPPL-10 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/05/1995 | SUPPL-9 | Labeling |
Label is not available on this site. |
||
| 07/25/1995 | SUPPL-8 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 03/17/1995 | SUPPL-7 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 08/17/1993 | SUPPL-6 | Labeling |
Label is not available on this site. |
||
| 07/28/1992 | SUPPL-5 | Labeling |
Label is not available on this site. |
||
| 04/02/1992 | SUPPL-4 | Labeling |
Label is not available on this site. |
||
| 07/31/1991 | SUPPL-3 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 06/21/1989 | SUPPL-2 | Labeling |
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 PHARMS LTD |
| DESIPRAMINE HYDROCHLORIDE | DESIPRAMINE HYDROCHLORIDE | 75MG | TABLET;ORAL | Prescription | No | AB | 208105 | AMNEAL PHARMS CO |
| DESIPRAMINE HYDROCHLORIDE | DESIPRAMINE HYDROCHLORIDE | 75MG | TABLET;ORAL | Prescription | No | AB | 207433 | HERITAGE PHARMS |
| DESIPRAMINE HYDROCHLORIDE | DESIPRAMINE HYDROCHLORIDE | 75MG | TABLET;ORAL | Prescription | No | AB | 204963 | NOVAST LABS |
| DESIPRAMINE HYDROCHLORIDE | DESIPRAMINE HYDROCHLORIDE | 75MG | TABLET;ORAL | Prescription | No | AB | 072102 | SANDOZ |
| NORPRAMIN | DESIPRAMINE HYDROCHLORIDE | 75MG | TABLET;ORAL | Prescription | Yes | AB | 014399 | VALIDUS PHARMS |