Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 014399
Company: VALIDUS PHARMS
Company: VALIDUS PHARMS
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| NORPRAMIN | DESIPRAMINE HYDROCHLORIDE | 25MG | TABLET;ORAL | Prescription | AB | Yes | No |
| NORPRAMIN | DESIPRAMINE HYDROCHLORIDE | 50MG | TABLET;ORAL | Prescription | AB | Yes | No |
| NORPRAMIN | DESIPRAMINE HYDROCHLORIDE | 75MG | TABLET;ORAL | Prescription | AB | Yes | No |
| NORPRAMIN | DESIPRAMINE HYDROCHLORIDE | 100MG | TABLET;ORAL | Prescription | AB | Yes | Yes |
| NORPRAMIN | DESIPRAMINE HYDROCHLORIDE | 150MG | TABLET;ORAL | Prescription | AB | Yes | No |
| NORPRAMIN | DESIPRAMINE HYDROCHLORIDE | 10MG | 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 |
|---|---|---|---|---|---|---|---|
| 11/20/1964 | ORIG-1 | Approval | Type 2 - New Active Ingredient | 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 |
|---|---|---|---|---|---|
| 11/09/2018 | SUPPL-71 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/014399s071lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/014399Orig1s071ltr.pdf | |
| 07/02/2014 | SUPPL-69 | Labeling-Medication Guide |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/014399s069lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/014399Orig1s069ltr.pdf | |
| 08/07/2014 | SUPPL-68 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 11/19/2012 | SUPPL-67 | Labeling-Package Insert, Labeling-Medication Guide |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/014399s066s067lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/014399Orig1s066,s067ltr.pdf | |
| 11/19/2012 | SUPPL-66 | Labeling-Package Insert, Labeling-Medication Guide |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/014399s066s067lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/014399Orig1s066,s067ltr.pdf | |
| 10/26/2009 | SUPPL-65 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/014399s065lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/014399s065ltr.pdf | |
| 07/30/2007 | SUPPL-64 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/014399s064lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/014399s064ltr.pdf | |
| 04/11/2006 | SUPPL-63 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/014399s063lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/014399s063ltr.pdf | |
| 01/12/2005 | SUPPL-62 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/14399s062lBL.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/14399s062ltr.pdf | |
| 05/23/2000 | SUPPL-61 | Labeling |
Label is not available on this site. |
||
| 05/23/2000 | SUPPL-60 | Labeling |
Label is not available on this site. |
||
| 05/23/2000 | SUPPL-58 | Labeling |
Label is not available on this site. |
||
| 09/03/1992 | SUPPL-56 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 05/23/2000 | SUPPL-55 | Labeling |
Label is not available on this site. |
||
| 12/11/1991 | SUPPL-53 | Labeling |
Label is not available on this site. |
||
| 12/11/1991 | SUPPL-52 | Labeling |
Label is not available on this site. |
||
| 06/19/1989 | SUPPL-51 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/25/1990 | SUPPL-50 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 12/10/1990 | SUPPL-49 | Labeling |
Label is not available on this site. |
||
| 03/21/1989 | SUPPL-48 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 03/30/1988 | SUPPL-47 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 06/20/1988 | SUPPL-46 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 11/15/1988 | SUPPL-45 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 04/03/1987 | SUPPL-44 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 06/24/1986 | SUPPL-43 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 12/10/1990 | SUPPL-42 | Labeling |
Label is not available on this site. |
||
| 04/29/1985 | SUPPL-40 | Labeling |
Label is not available on this site. |
||
| 06/22/1982 | SUPPL-38 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 06/22/1982 | SUPPL-37 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 02/01/1982 | SUPPL-36 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 02/01/1982 | SUPPL-35 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 02/01/1982 | SUPPL-34 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 02/11/1982 | SUPPL-33 | Manufacturing (CMC)-Formulation |
Label is not available on this site. |
||
| 02/01/1982 | SUPPL-32 | Manufacturing (CMC)-Formulation |
Label is not available on this site. |
||
| 07/28/1980 | SUPPL-31 | Labeling |
Label is not available on this site. |
||
| 08/18/1980 | SUPPL-30 | Labeling |
Label is not available on this site. |
||
| 02/14/1980 | SUPPL-29 | Manufacturing (CMC)-Formulation |
Label is not available on this site. |
||
| 03/01/1977 | SUPPL-27 | Labeling |
Label is not available on this site. |
||
| 10/06/1975 | SUPPL-23 | Labeling |
Label is not available on this site. |
||
| 05/28/1976 | SUPPL-22 | Labeling |
Label is not available on this site. |
||
| 04/15/1975 | SUPPL-21 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 06/25/1976 | SUPPL-20 | Efficacy |
Label is not available on this site. |
||
| 04/04/1975 | SUPPL-19 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 07/02/1974 | SUPPL-18 | Manufacturing (CMC)-Control |
Label is not available on this site. |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 11/09/2018 | SUPPL-71 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/014399s071lbl.pdf | |
| 07/02/2014 | SUPPL-69 | Labeling-Medication Guide | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/014399s069lbl.pdf | |
| 11/19/2012 | SUPPL-67 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/014399s066s067lbl.pdf | |
| 11/19/2012 | SUPPL-67 | Labeling-Medication Guide | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/014399s066s067lbl.pdf | |
| 11/19/2012 | SUPPL-66 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/014399s066s067lbl.pdf | |
| 11/19/2012 | SUPPL-66 | Labeling-Medication Guide | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/014399s066s067lbl.pdf | |
| 10/26/2009 | SUPPL-65 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/014399s065lbl.pdf | |
| 07/30/2007 | SUPPL-64 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/014399s064lbl.pdf | |
| 04/11/2006 | SUPPL-63 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/014399s063lbl.pdf | |
| 01/12/2005 | SUPPL-62 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/14399s062lBL.pdf |
NORPRAMIN
TABLET;ORAL; 25MG
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| DESIPRAMINE HYDROCHLORIDE | DESIPRAMINE HYDROCHLORIDE | 25MG | TABLET;ORAL | Prescription | No | AB | 071601 | ACTAVIS TOTOWA |
| DESIPRAMINE HYDROCHLORIDE | DESIPRAMINE HYDROCHLORIDE | 25MG | TABLET;ORAL | Prescription | No | AB | 209785 | ALEMBIC |
| DESIPRAMINE HYDROCHLORIDE | DESIPRAMINE HYDROCHLORIDE | 25MG | TABLET;ORAL | Prescription | No | AB | 208105 | AMNEAL PHARMS CO |
| DESIPRAMINE HYDROCHLORIDE | DESIPRAMINE HYDROCHLORIDE | 25MG | TABLET;ORAL | Prescription | No | AB | 072103 | CHARTWELL RX |
| DESIPRAMINE HYDROCHLORIDE | DESIPRAMINE HYDROCHLORIDE | 25MG | TABLET;ORAL | Prescription | No | AB | 207433 | HERITAGE PHARMS |
| DESIPRAMINE HYDROCHLORIDE | DESIPRAMINE HYDROCHLORIDE | 25MG | TABLET;ORAL | Prescription | No | AB | 204963 | NOVAST LABS |
| NORPRAMIN | DESIPRAMINE HYDROCHLORIDE | 25MG | TABLET;ORAL | Prescription | Yes | AB | 014399 | VALIDUS PHARMS |
TABLET;ORAL; 50MG
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| DESIPRAMINE HYDROCHLORIDE | DESIPRAMINE HYDROCHLORIDE | 50MG | TABLET;ORAL | Prescription | No | AB | 071588 | ACTAVIS TOTOWA |
| DESIPRAMINE HYDROCHLORIDE | DESIPRAMINE HYDROCHLORIDE | 50MG | TABLET;ORAL | Prescription | No | AB | 209785 | ALEMBIC |
| DESIPRAMINE HYDROCHLORIDE | DESIPRAMINE HYDROCHLORIDE | 50MG | TABLET;ORAL | Prescription | No | AB | 208105 | AMNEAL PHARMS CO |
| DESIPRAMINE HYDROCHLORIDE | DESIPRAMINE HYDROCHLORIDE | 50MG | TABLET;ORAL | Prescription | No | AB | 072103 | CHARTWELL RX |
| DESIPRAMINE HYDROCHLORIDE | DESIPRAMINE HYDROCHLORIDE | 50MG | TABLET;ORAL | Prescription | No | AB | 207433 | HERITAGE PHARMS |
| DESIPRAMINE HYDROCHLORIDE | DESIPRAMINE HYDROCHLORIDE | 50MG | TABLET;ORAL | Prescription | No | AB | 204963 | NOVAST LABS |
| NORPRAMIN | DESIPRAMINE HYDROCHLORIDE | 50MG | TABLET;ORAL | Prescription | Yes | AB | 014399 | VALIDUS PHARMS |
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 PHARMS |
| 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 |
TABLET;ORAL; 100MG
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| DESIPRAMINE HYDROCHLORIDE | DESIPRAMINE HYDROCHLORIDE | 100MG | TABLET;ORAL | Prescription | No | AB | 071766 | ACTAVIS TOTOWA |
| DESIPRAMINE HYDROCHLORIDE | DESIPRAMINE HYDROCHLORIDE | 100MG | TABLET;ORAL | Prescription | No | AB | 209785 | ALEMBIC |
| DESIPRAMINE HYDROCHLORIDE | DESIPRAMINE HYDROCHLORIDE | 100MG | TABLET;ORAL | Prescription | No | AB | 208105 | AMNEAL PHARMS CO |
| DESIPRAMINE HYDROCHLORIDE | DESIPRAMINE HYDROCHLORIDE | 100MG | TABLET;ORAL | Prescription | No | AB | 072103 | CHARTWELL RX |
| DESIPRAMINE HYDROCHLORIDE | DESIPRAMINE HYDROCHLORIDE | 100MG | TABLET;ORAL | Prescription | No | AB | 207433 | HERITAGE PHARMS |
| DESIPRAMINE HYDROCHLORIDE | DESIPRAMINE HYDROCHLORIDE | 100MG | TABLET;ORAL | Prescription | No | AB | 204963 | NOVAST LABS |
| NORPRAMIN | DESIPRAMINE HYDROCHLORIDE | 100MG | TABLET;ORAL | Prescription | Yes | AB | 014399 | VALIDUS PHARMS |
TABLET;ORAL; 150MG
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| DESIPRAMINE HYDROCHLORIDE | DESIPRAMINE HYDROCHLORIDE | 150MG | TABLET;ORAL | Prescription | No | AB | 074430 | ACTAVIS TOTOWA |
| DESIPRAMINE HYDROCHLORIDE | DESIPRAMINE HYDROCHLORIDE | 150MG | TABLET;ORAL | Prescription | No | AB | 209785 | ALEMBIC |
| DESIPRAMINE HYDROCHLORIDE | DESIPRAMINE HYDROCHLORIDE | 150MG | TABLET;ORAL | Prescription | No | AB | 208105 | AMNEAL PHARMS CO |
| DESIPRAMINE HYDROCHLORIDE | DESIPRAMINE HYDROCHLORIDE | 150MG | TABLET;ORAL | Prescription | No | AB | 072103 | CHARTWELL RX |
| DESIPRAMINE HYDROCHLORIDE | DESIPRAMINE HYDROCHLORIDE | 150MG | TABLET;ORAL | Prescription | No | AB | 207433 | HERITAGE PHARMS |
| DESIPRAMINE HYDROCHLORIDE | DESIPRAMINE HYDROCHLORIDE | 150MG | TABLET;ORAL | Prescription | No | AB | 204963 | NOVAST LABS |
| NORPRAMIN | DESIPRAMINE HYDROCHLORIDE | 150MG | TABLET;ORAL | Prescription | Yes | AB | 014399 | VALIDUS PHARMS |
TABLET;ORAL; 10MG
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| DESIPRAMINE HYDROCHLORIDE | DESIPRAMINE HYDROCHLORIDE | 10MG | TABLET;ORAL | Prescription | No | AB | 074430 | ACTAVIS TOTOWA |
| DESIPRAMINE HYDROCHLORIDE | DESIPRAMINE HYDROCHLORIDE | 10MG | TABLET;ORAL | Prescription | No | AB | 209785 | ALEMBIC |
| DESIPRAMINE HYDROCHLORIDE | DESIPRAMINE HYDROCHLORIDE | 10MG | TABLET;ORAL | Prescription | No | AB | 208105 | AMNEAL PHARMS CO |
| DESIPRAMINE HYDROCHLORIDE | DESIPRAMINE HYDROCHLORIDE | 10MG | TABLET;ORAL | Prescription | No | AB | 072103 | CHARTWELL RX |
| DESIPRAMINE HYDROCHLORIDE | DESIPRAMINE HYDROCHLORIDE | 10MG | TABLET;ORAL | Prescription | No | AB | 207433 | HERITAGE PHARMS |
| DESIPRAMINE HYDROCHLORIDE | DESIPRAMINE HYDROCHLORIDE | 10MG | TABLET;ORAL | Prescription | No | AB | 204963 | NOVAST LABS |
| NORPRAMIN | DESIPRAMINE HYDROCHLORIDE | 10MG | TABLET;ORAL | Prescription | Yes | AB | 014399 | VALIDUS PHARMS |