Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 014399
Company: US PHARM HOLDINGS
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
NORPRAMIN DESIPRAMINE HYDROCHLORIDE 25MG TABLET;ORAL Prescription AB Yes No
NORPRAMIN DESIPRAMINE HYDROCHLORIDE 50MG TABLET;ORAL Prescription AB Yes No
NORPRAMIN DESIPRAMINE HYDROCHLORIDE 75MG TABLET;ORAL Prescription AB Yes No
NORPRAMIN DESIPRAMINE HYDROCHLORIDE 100MG TABLET;ORAL Prescription AB Yes Yes
NORPRAMIN DESIPRAMINE HYDROCHLORIDE 150MG TABLET;ORAL Prescription AB Yes No
NORPRAMIN DESIPRAMINE HYDROCHLORIDE 10MG TABLET;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
11/20/1964 ORIG-1 Approval Type 2 - New Active Ingredient 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
07/02/2014 SUPPL-69 Labeling-Medication Guide Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/014399s069lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/014399Orig1s069ltr.pdf
08/07/2014 SUPPL-68 Manufacturing (CMC)

Label is not available on this site.

11/19/2012 SUPPL-67 Labeling-Medication Guide, Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/014399s066s067lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/014399Orig1s066,s067ltr.pdf
11/19/2012 SUPPL-66 Labeling-Medication Guide, Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/014399s066s067lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/014399Orig1s066,s067ltr.pdf
10/26/2009 SUPPL-65 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/014399s065lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/014399s065ltr.pdf
07/30/2007 SUPPL-64 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/014399s064lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/014399s064ltr.pdf
04/11/2006 SUPPL-63 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/014399s063lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/014399s063ltr.pdf
01/12/2005 SUPPL-62 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/14399s062lBL.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/14399s062ltr.pdf
05/23/2000 SUPPL-61 Labeling

Label is not available on this site.

05/23/2000 SUPPL-60 Labeling

Label is not available on this site.

05/23/2000 SUPPL-58 Labeling

Label is not available on this site.

09/03/1992 SUPPL-56 Manufacturing (CMC)

Label is not available on this site.

05/23/2000 SUPPL-55 Labeling

Label is not available on this site.

12/11/1991 SUPPL-53 Labeling

Label is not available on this site.

12/11/1991 SUPPL-52 Labeling

Label is not available on this site.

06/19/1989 SUPPL-51 Manufacturing (CMC)

Label is not available on this site.

04/25/1990 SUPPL-50 Manufacturing (CMC)-Control

Label is not available on this site.

12/10/1990 SUPPL-49 Labeling

Label is not available on this site.

03/21/1989 SUPPL-48 Manufacturing (CMC)

Label is not available on this site.

03/30/1988 SUPPL-47 Manufacturing (CMC)

Label is not available on this site.

06/20/1988 SUPPL-46 Manufacturing (CMC)-Packaging

Label is not available on this site.

11/15/1988 SUPPL-45 Manufacturing (CMC)-Packaging

Label is not available on this site.

04/03/1987 SUPPL-44 Manufacturing (CMC)-Control

Label is not available on this site.

06/24/1986 SUPPL-43 Manufacturing (CMC)-Control

Label is not available on this site.

12/10/1990 SUPPL-42 Labeling

Label is not available on this site.

04/29/1985 SUPPL-40 Labeling

Label is not available on this site.

06/22/1982 SUPPL-38 Manufacturing (CMC)

Label is not available on this site.

06/22/1982 SUPPL-37 Manufacturing (CMC)-Control

Label is not available on this site.

02/01/1982 SUPPL-36 Manufacturing (CMC)-Control

Label is not available on this site.

02/01/1982 SUPPL-35 Manufacturing (CMC)-Control

Label is not available on this site.

02/01/1982 SUPPL-34 Manufacturing (CMC)-Packaging

Label is not available on this site.

02/11/1982 SUPPL-33 Manufacturing (CMC)-Formulation

Label is not available on this site.

02/01/1982 SUPPL-32 Manufacturing (CMC)-Formulation

Label is not available on this site.

07/28/1980 SUPPL-31 Labeling

Label is not available on this site.

08/18/1980 SUPPL-30 Labeling

Label is not available on this site.

02/14/1980 SUPPL-29 Manufacturing (CMC)-Formulation

Label is not available on this site.

03/01/1977 SUPPL-27 Labeling

Label is not available on this site.

10/06/1975 SUPPL-23 Labeling

Label is not available on this site.

05/28/1976 SUPPL-22 Labeling

Label is not available on this site.

04/15/1975 SUPPL-21 Manufacturing (CMC)-Control

Label is not available on this site.

06/25/1976 SUPPL-20 Efficacy

Label is not available on this site.

04/04/1975 SUPPL-19 Manufacturing (CMC)-Control

Label is not available on this site.

07/02/1974 SUPPL-18 Manufacturing (CMC)-Control

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
07/02/2014 SUPPL-69 Labeling-Medication Guide Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/014399s069lbl.pdf
11/19/2012 SUPPL-67 Labeling-Medication Guide Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/014399s066s067lbl.pdf
11/19/2012 SUPPL-67 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/014399s066s067lbl.pdf
11/19/2012 SUPPL-66 Labeling-Medication Guide Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/014399s066s067lbl.pdf
11/19/2012 SUPPL-66 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/014399s066s067lbl.pdf
10/26/2009 SUPPL-65 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/014399s065lbl.pdf
07/30/2007 SUPPL-64 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/014399s064lbl.pdf
04/11/2006 SUPPL-63 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/014399s063lbl.pdf
01/12/2005 SUPPL-62 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/14399s062lBL.pdf

NORPRAMIN

TABLET;ORAL; 25MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
DESIPRAMINE HYDROCHLORIDE DESIPRAMINE HYDROCHLORIDE 25MG TABLET;ORAL Prescription No AB 071601 ACTAVIS TOTOWA
DESIPRAMINE HYDROCHLORIDE DESIPRAMINE HYDROCHLORIDE 25MG TABLET;ORAL Prescription No AB 208105 AMNEAL PHARMS CO
DESIPRAMINE HYDROCHLORIDE DESIPRAMINE HYDROCHLORIDE 25MG TABLET;ORAL Prescription No AB 207433 HERITAGE PHARMS INC
DESIPRAMINE HYDROCHLORIDE DESIPRAMINE HYDROCHLORIDE 25MG TABLET;ORAL Prescription No AB 205153 IMPAX LABS INC
DESIPRAMINE HYDROCHLORIDE DESIPRAMINE HYDROCHLORIDE 25MG TABLET;ORAL Prescription No AB 072100 SANDOZ
NORPRAMIN DESIPRAMINE HYDROCHLORIDE 25MG TABLET;ORAL Prescription Yes AB 014399 US PHARM HOLDINGS

TABLET;ORAL; 50MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
DESIPRAMINE HYDROCHLORIDE DESIPRAMINE HYDROCHLORIDE 50MG TABLET;ORAL Prescription No AB 071588 ACTAVIS TOTOWA
DESIPRAMINE HYDROCHLORIDE DESIPRAMINE HYDROCHLORIDE 50MG TABLET;ORAL Prescription No AB 208105 AMNEAL PHARMS CO
DESIPRAMINE HYDROCHLORIDE DESIPRAMINE HYDROCHLORIDE 50MG TABLET;ORAL Prescription No AB 207433 HERITAGE PHARMS INC
DESIPRAMINE HYDROCHLORIDE DESIPRAMINE HYDROCHLORIDE 50MG TABLET;ORAL Prescription No AB 205153 IMPAX LABS INC
DESIPRAMINE HYDROCHLORIDE DESIPRAMINE HYDROCHLORIDE 50MG TABLET;ORAL Prescription No AB 072101 SANDOZ
NORPRAMIN DESIPRAMINE HYDROCHLORIDE 50MG TABLET;ORAL Prescription Yes AB 014399 US PHARM HOLDINGS

TABLET;ORAL; 75MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
DESIPRAMINE HYDROCHLORIDE DESIPRAMINE HYDROCHLORIDE 75MG TABLET;ORAL Prescription No AB 071602 ACTAVIS TOTOWA
DESIPRAMINE HYDROCHLORIDE DESIPRAMINE HYDROCHLORIDE 75MG TABLET;ORAL Prescription No AB 208105 AMNEAL PHARMS CO
DESIPRAMINE HYDROCHLORIDE DESIPRAMINE HYDROCHLORIDE 75MG TABLET;ORAL Prescription No AB 207433 HERITAGE PHARMS INC
DESIPRAMINE HYDROCHLORIDE DESIPRAMINE HYDROCHLORIDE 75MG TABLET;ORAL Prescription No AB 205153 IMPAX LABS INC
DESIPRAMINE HYDROCHLORIDE DESIPRAMINE HYDROCHLORIDE 75MG TABLET;ORAL Prescription No AB 072102 SANDOZ
NORPRAMIN DESIPRAMINE HYDROCHLORIDE 75MG TABLET;ORAL Prescription Yes AB 014399 US PHARM HOLDINGS

TABLET;ORAL; 100MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
DESIPRAMINE HYDROCHLORIDE DESIPRAMINE HYDROCHLORIDE 100MG TABLET;ORAL Prescription No AB 071766 ACTAVIS TOTOWA
DESIPRAMINE HYDROCHLORIDE DESIPRAMINE HYDROCHLORIDE 100MG TABLET;ORAL Prescription No AB 208105 AMNEAL PHARMS CO
DESIPRAMINE HYDROCHLORIDE DESIPRAMINE HYDROCHLORIDE 100MG TABLET;ORAL Prescription No AB 207433 HERITAGE PHARMS INC
DESIPRAMINE HYDROCHLORIDE DESIPRAMINE HYDROCHLORIDE 100MG TABLET;ORAL Prescription No AB 205153 IMPAX LABS INC
DESIPRAMINE HYDROCHLORIDE DESIPRAMINE HYDROCHLORIDE 100MG TABLET;ORAL Prescription No AB 072103 SANDOZ
NORPRAMIN DESIPRAMINE HYDROCHLORIDE 100MG TABLET;ORAL Prescription Yes AB 014399 US PHARM HOLDINGS

TABLET;ORAL; 150MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
DESIPRAMINE HYDROCHLORIDE DESIPRAMINE HYDROCHLORIDE 150MG TABLET;ORAL Prescription No AB 074430 ACTAVIS TOTOWA
DESIPRAMINE HYDROCHLORIDE DESIPRAMINE HYDROCHLORIDE 150MG TABLET;ORAL Prescription No AB 208105 AMNEAL PHARMS CO
DESIPRAMINE HYDROCHLORIDE DESIPRAMINE HYDROCHLORIDE 150MG TABLET;ORAL Prescription No AB 207433 HERITAGE PHARMS INC
DESIPRAMINE HYDROCHLORIDE DESIPRAMINE HYDROCHLORIDE 150MG TABLET;ORAL Prescription No AB 205153 IMPAX LABS INC
DESIPRAMINE HYDROCHLORIDE DESIPRAMINE HYDROCHLORIDE 150MG TABLET;ORAL Prescription No AB 072104 SANDOZ
NORPRAMIN DESIPRAMINE HYDROCHLORIDE 150MG TABLET;ORAL Prescription Yes AB 014399 US PHARM HOLDINGS

TABLET;ORAL; 10MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
DESIPRAMINE HYDROCHLORIDE DESIPRAMINE HYDROCHLORIDE 10MG TABLET;ORAL Prescription No AB 074430 ACTAVIS TOTOWA
DESIPRAMINE HYDROCHLORIDE DESIPRAMINE HYDROCHLORIDE 10MG TABLET;ORAL Prescription No AB 208105 AMNEAL PHARMS CO
DESIPRAMINE HYDROCHLORIDE DESIPRAMINE HYDROCHLORIDE 10MG TABLET;ORAL Prescription No AB 207433 HERITAGE PHARMS INC
DESIPRAMINE HYDROCHLORIDE DESIPRAMINE HYDROCHLORIDE 10MG TABLET;ORAL Prescription No AB 205153 IMPAX LABS INC
DESIPRAMINE HYDROCHLORIDE DESIPRAMINE HYDROCHLORIDE 10MG TABLET;ORAL Prescription No AB 072099 SANDOZ
NORPRAMIN DESIPRAMINE HYDROCHLORIDE 10MG TABLET;ORAL Prescription Yes AB 014399 US PHARM HOLDINGS

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