Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 090444
Company: LUPIN LTD
Company: LUPIN LTD
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| IMIPRAMINE PAMOATE | IMIPRAMINE PAMOATE | EQ 75MG HYDROCHLORIDE | CAPSULE;ORAL | Prescription | AB | No | No |
| IMIPRAMINE PAMOATE | IMIPRAMINE PAMOATE | EQ 100MG HYDROCHLORIDE | CAPSULE;ORAL | Prescription | AB | No | No |
| IMIPRAMINE PAMOATE | IMIPRAMINE PAMOATE | EQ 125MG HYDROCHLORIDE | CAPSULE;ORAL | Prescription | AB | No | No |
| IMIPRAMINE PAMOATE | IMIPRAMINE PAMOATE | EQ 150MG HYDROCHLORIDE | CAPSULE;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 |
|---|---|---|---|---|---|---|---|
| 04/16/2010 | 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 |
|---|---|---|---|---|---|
| 12/21/2014 | SUPPL-5 | Labeling-Package Insert, Labeling-Medication Guide |
Label is not available on this site. |
||
| 12/21/2014 | SUPPL-3 | Labeling-Package Insert |
Label is not available on this site. |
IMIPRAMINE PAMOATE
CAPSULE;ORAL; EQ 75MG HYDROCHLORIDE
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| IMIPRAMINE PAMOATE | IMIPRAMINE PAMOATE | EQ 75MG HYDROCHLORIDE | CAPSULE;ORAL | Prescription | No | AB | 091099 | HIKMA |
| IMIPRAMINE PAMOATE | IMIPRAMINE PAMOATE | EQ 75MG HYDROCHLORIDE | CAPSULE;ORAL | Prescription | No | AB | 090444 | LUPIN LTD |
CAPSULE;ORAL; EQ 100MG HYDROCHLORIDE
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| IMIPRAMINE PAMOATE | IMIPRAMINE PAMOATE | EQ 100MG HYDROCHLORIDE | CAPSULE;ORAL | Prescription | No | AB | 091099 | HIKMA |
| IMIPRAMINE PAMOATE | IMIPRAMINE PAMOATE | EQ 100MG HYDROCHLORIDE | CAPSULE;ORAL | Prescription | No | AB | 090444 | LUPIN LTD |
CAPSULE;ORAL; EQ 125MG HYDROCHLORIDE
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| IMIPRAMINE PAMOATE | IMIPRAMINE PAMOATE | EQ 125MG HYDROCHLORIDE | CAPSULE;ORAL | Prescription | No | AB | 091099 | HIKMA |
| IMIPRAMINE PAMOATE | IMIPRAMINE PAMOATE | EQ 125MG HYDROCHLORIDE | CAPSULE;ORAL | Prescription | No | AB | 090444 | LUPIN LTD |
CAPSULE;ORAL; EQ 150MG HYDROCHLORIDE
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| IMIPRAMINE PAMOATE | IMIPRAMINE PAMOATE | EQ 150MG HYDROCHLORIDE | CAPSULE;ORAL | Prescription | No | AB | 091099 | HIKMA |
| IMIPRAMINE PAMOATE | IMIPRAMINE PAMOATE | EQ 150MG HYDROCHLORIDE | CAPSULE;ORAL | Prescription | No | AB | 090444 | LUPIN LTD |