Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 204963
Company: INGENUS PHARMS LLC
Company: INGENUS PHARMS LLC
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| DESIPRAMINE HYDROCHLORIDE | DESIPRAMINE HYDROCHLORIDE | 10MG | TABLET;ORAL | Prescription | AB | No | No |
| DESIPRAMINE HYDROCHLORIDE | DESIPRAMINE HYDROCHLORIDE | 25MG | TABLET;ORAL | Prescription | AB | No | No |
| DESIPRAMINE HYDROCHLORIDE | DESIPRAMINE HYDROCHLORIDE | 50MG | TABLET;ORAL | Prescription | AB | No | No |
| DESIPRAMINE HYDROCHLORIDE | DESIPRAMINE HYDROCHLORIDE | 75MG | TABLET;ORAL | Prescription | AB | No | No |
| DESIPRAMINE HYDROCHLORIDE | DESIPRAMINE HYDROCHLORIDE | 100MG | TABLET;ORAL | Prescription | AB | No | No |
| DESIPRAMINE HYDROCHLORIDE | DESIPRAMINE HYDROCHLORIDE | 150MG | 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 |
|---|---|---|---|---|---|---|---|
| 12/26/2017 | ORIG-1 | Approval | 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 |
|---|---|---|---|---|---|
| 10/23/2025 | SUPPL-6 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
||
| 06/12/2023 | SUPPL-4 | Labeling-Package Insert, Labeling-Medication Guide, Labeling-Container/Carton Labels |
Label is not available on this site. |
||
| 09/30/2019 | SUPPL-2 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
||
| 03/16/2021 | SUPPL-1 | Labeling |
Label is not available on this site. |
DESIPRAMINE HYDROCHLORIDE
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 | 204963 | INGENUS PHARMS LLC |
| NORPRAMIN | DESIPRAMINE HYDROCHLORIDE | 10MG | TABLET;ORAL | Prescription | Yes | AB | 014399 | VALIDUS PHARMS |
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 | 204963 | INGENUS PHARMS LLC |
| 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 | 204963 | INGENUS PHARMS LLC |
| 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 | 204963 | INGENUS PHARMS LLC |
| 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 | 204963 | INGENUS PHARMS LLC |
| 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 | 204963 | INGENUS PHARMS LLC |
| NORPRAMIN | DESIPRAMINE HYDROCHLORIDE | 150MG | TABLET;ORAL | Prescription | Yes | AB | 014399 | VALIDUS PHARMS |