Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 208127
Company: BRECKENRIDGE
Company: BRECKENRIDGE
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
TRIMIPRAMINE MALEATE | TRIMIPRAMINE MALEATE | EQ 25MG BASE | CAPSULE;ORAL | Prescription | AB | No | No |
TRIMIPRAMINE MALEATE | TRIMIPRAMINE MALEATE | EQ 50MG BASE | CAPSULE;ORAL | Prescription | AB | No | Yes |
TRIMIPRAMINE MALEATE | TRIMIPRAMINE MALEATE | EQ 100MG BASE | 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 |
---|---|---|---|---|---|---|---|
04/15/2016 | ORIG-1 | Approval | STANDARD |
Label is not available on this site. |
TRIMIPRAMINE MALEATE
CAPSULE;ORAL; EQ 25MG BASE
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
TRIMIPRAMINE MALEATE | TRIMIPRAMINE MALEATE | EQ 25MG BASE | CAPSULE;ORAL | Prescription | No | AB | 208127 | BRECKENRIDGE |
TRIMIPRAMINE MALEATE | TRIMIPRAMINE MALEATE | EQ 25MG BASE | CAPSULE;ORAL | Prescription | No | AB | 077361 | ELITE LABS INC |
CAPSULE;ORAL; EQ 50MG BASE
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
TRIMIPRAMINE MALEATE | TRIMIPRAMINE MALEATE | EQ 50MG BASE | CAPSULE;ORAL | Prescription | No | AB | 208127 | BRECKENRIDGE |
TRIMIPRAMINE MALEATE | TRIMIPRAMINE MALEATE | EQ 50MG BASE | CAPSULE;ORAL | Prescription | No | AB | 077361 | ELITE LABS INC |
CAPSULE;ORAL; EQ 100MG BASE
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
TRIMIPRAMINE MALEATE | TRIMIPRAMINE MALEATE | EQ 100MG BASE | CAPSULE;ORAL | Prescription | No | AB | 208127 | BRECKENRIDGE |
TRIMIPRAMINE MALEATE | TRIMIPRAMINE MALEATE | EQ 100MG BASE | CAPSULE;ORAL | Prescription | No | AB | 077361 | ELITE LABS INC |