Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 016792
Company: ODYSSEY PHARMS
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
SURMONTIL TRIMIPRAMINE MALEATE EQ 25MG BASE CAPSULE;ORAL Prescription AB Yes No
SURMONTIL TRIMIPRAMINE MALEATE EQ 50MG BASE CAPSULE;ORAL Prescription AB Yes Yes
SURMONTIL TRIMIPRAMINE MALEATE EQ 100MG BASE CAPSULE;ORAL Prescription AB Yes 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
06/12/1979 ORIG-1 Approval Type 1 - New Molecular Entity 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
07/17/2014 SUPPL-37 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/016792s037lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/016792Orig1s037ltr.pdf
09/30/2014 SUPPL-36 Manufacturing (CMC)

Label is not available on this site.

12/23/2013 SUPPL-35 Manufacturing (CMC)

Label is not available on this site.

12/03/2012 SUPPL-34 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/016792s034lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/016792Orig1s034ltr.pdf
08/01/2007 SUPPL-25 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/016792s025lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/016792s025ltr.pdf
01/12/2005 SUPPL-24 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/16792s024lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/16792s024ltr.pdf
05/01/2000 SUPPL-20 Labeling Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/16792S020.pdf
04/27/2000 SUPPL-19 Labeling Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/16792S015.pdf
04/27/2000 SUPPL-18 Labeling Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/16792S015.pdf
04/03/1992 SUPPL-17 Manufacturing (CMC)-Control

Label is not available on this site.

04/03/1992 SUPPL-16 Manufacturing (CMC)

Label is not available on this site.

04/27/2000 SUPPL-15 Labeling Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/16792S015.pdf
12/16/1991 SUPPL-14 Manufacturing (CMC)-Control

Label is not available on this site.

04/20/1988 SUPPL-12 Manufacturing (CMC)

Label is not available on this site.

06/17/1988 SUPPL-11 Manufacturing (CMC)-Packaging

Label is not available on this site.

07/24/1987 SUPPL-10 Manufacturing (CMC)

Label is not available on this site.

02/02/1987 SUPPL-9 Manufacturing (CMC)-Packaging

Label is not available on this site.

11/12/1982 SUPPL-6 Manufacturing (CMC)-Packaging

Label is not available on this site.

10/05/1982 SUPPL-5 Manufacturing (CMC)-Packaging

Label is not available on this site.

08/24/1981 SUPPL-4 Manufacturing (CMC)-Control

Label is not available on this site.

09/15/1982 SUPPL-3 Manufacturing (CMC)-Formulation

Label is not available on this site.

03/26/1981 SUPPL-2 Manufacturing (CMC)-Packaging

Label is not available on this site.

07/08/1980 SUPPL-1 Labeling

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
07/17/2014 SUPPL-37 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/016792s037lbl.pdf
12/03/2012 SUPPL-34 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/016792s034lbl.pdf
08/01/2007 SUPPL-25 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/016792s025lbl.pdf
01/12/2005 SUPPL-24 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/16792s024lbl.pdf

SURMONTIL

CAPSULE;ORAL; EQ 25MG BASE
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
SURMONTIL TRIMIPRAMINE MALEATE EQ 25MG BASE CAPSULE;ORAL Prescription Yes AB 016792 ODYSSEY PHARMS
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
SURMONTIL TRIMIPRAMINE MALEATE EQ 50MG BASE CAPSULE;ORAL Prescription Yes AB 016792 ODYSSEY PHARMS
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
SURMONTIL TRIMIPRAMINE MALEATE EQ 100MG BASE CAPSULE;ORAL Prescription Yes AB 016792 ODYSSEY PHARMS
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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