Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 077361
Company: ELITE LABS INC
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 No
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
08/02/2006 ORIG-1 Approval Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/077361s000LTR.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
12/27/2018 SUPPL-8 Labeling-Package Insert, Labeling-Container/Carton Labels

Label is not available on this site.

03/18/2015 SUPPL-6 Labeling-Medication Guide, Labeling-Package Insert

Label is not available on this site.

03/18/2015 SUPPL-5 Labeling-Package Insert, Labeling-Container/Carton Labels

Label is not available on this site.

03/18/2015 SUPPL-4 Labeling-Package Insert, Labeling-Container/Carton Labels

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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