Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 208105
Company: AMNEAL PHARMS CO
Company: AMNEAL PHARMS CO
| 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 |
|---|---|---|---|---|---|---|---|
| 03/17/2016 | 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 |
|---|---|---|---|---|---|
| 06/05/2023 | SUPPL-7 | Labeling-Container/Carton Labels, Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
||
| 04/16/2019 | SUPPL-4 | Labeling-Medication Guide, Labeling-Package Insert |
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 | 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 |
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 |