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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 208127
Company: CROSSMEDIKA SA
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 CROSSMEDIKA SA
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 CROSSMEDIKA SA
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 CROSSMEDIKA SA
TRIMIPRAMINE MALEATE TRIMIPRAMINE MALEATE EQ 100MG BASE CAPSULE;ORAL Prescription No AB 077361 ELITE LABS INC
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