Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 018013
Company: MALLINCKRODT LLC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
PAMELOR NORTRIPTYLINE HYDROCHLORIDE EQ 10MG BASE CAPSULE;ORAL Prescription AB Yes No
PAMELOR NORTRIPTYLINE HYDROCHLORIDE EQ 25MG BASE CAPSULE;ORAL Prescription AB Yes No
PAMELOR NORTRIPTYLINE HYDROCHLORIDE EQ 75MG BASE CAPSULE;ORAL Prescription AB Yes Yes
PAMELOR NORTRIPTYLINE HYDROCHLORIDE EQ 50MG 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
08/01/1977 ORIG-1 Approval Type 5 - New Formulation or New Manufacturer 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
07/28/2014 SUPPL-63 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/018013s063lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/018012Orig1s031,018013Orig1s063,017090Orig1s078,019906Orig1s039ltr.pdf
07/10/2014 SUPPL-62 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/018013s062lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/018012Orig1s030,018013Orig1s062,017090Orig1s077,019906Orig1s038ltr.pdf
10/26/2012 SUPPL-61 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/018012s029,018013s061lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/019906Orig1s037,018012Orig1029,018013Orig1s061,017090Orig1s076ltr.pdf
07/13/2007 SUPPL-58 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/018013s58lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/017090s74,18012s27,18013s58,19906s34ltr.pdf
01/12/2005 SUPPL-56 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/18012s026,18013s056lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/18012s026,18013s056ltr.pdf
12/06/2004 SUPPL-55 Manufacturing (CMC)

Label is not available on this site.

06/07/2001 SUPPL-54 Manufacturing (CMC)

Label is not available on this site.

07/31/2001 SUPPL-53 Labeling Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/018013_s053_PAMELOR CAPSULES.pdf
04/27/2000 SUPPL-52 Manufacturing (CMC)

Label is not available on this site.

04/15/1999 SUPPL-51 Manufacturing (CMC)-Packaging

Label is not available on this site.

04/28/1999 SUPPL-50 Manufacturing (CMC)

Label is not available on this site.

12/07/1995 SUPPL-48 Manufacturing (CMC)

Label is not available on this site.

09/18/1995 SUPPL-47 Manufacturing (CMC)-Control

Label is not available on this site.

07/07/1994 SUPPL-44 Manufacturing (CMC)-Control

Label is not available on this site.

04/15/1994 SUPPL-43 Manufacturing (CMC)

Label is not available on this site.

04/01/1994 SUPPL-42 Manufacturing (CMC)-Packaging

Label is not available on this site.

10/06/1993 SUPPL-41 Labeling

Label is not available on this site.

07/23/1993 SUPPL-39 Manufacturing (CMC)-Packaging

Label is not available on this site.

08/17/1993 SUPPL-38 Manufacturing (CMC)-Formulation

Label is not available on this site.

06/16/1993 SUPPL-37 Manufacturing (CMC)-Control

Label is not available on this site.

06/16/1993 SUPPL-36 Manufacturing (CMC)-Control

Label is not available on this site.

06/10/1993 SUPPL-35 Manufacturing (CMC)-Control

Label is not available on this site.

07/23/1993 SUPPL-34 Manufacturing (CMC)-Control

Label is not available on this site.

01/21/1992 SUPPL-33 Manufacturing (CMC)

Label is not available on this site.

03/12/1992 SUPPL-32 Manufacturing (CMC)-Packaging

Label is not available on this site.

08/02/1991 SUPPL-31 Manufacturing (CMC)-Control

Label is not available on this site.

08/26/1993 SUPPL-30 Labeling

Label is not available on this site.

03/13/1991 SUPPL-29 Labeling

Label is not available on this site.

03/26/1990 SUPPL-26 Manufacturing (CMC)

Label is not available on this site.

11/07/1989 SUPPL-23 Manufacturing (CMC)-Packaging

Label is not available on this site.

11/07/1988 SUPPL-21 Manufacturing (CMC)-Packaging

Label is not available on this site.

01/16/1990 SUPPL-20 Manufacturing (CMC)-Packaging

Label is not available on this site.

08/25/1986 SUPPL-19 Manufacturing (CMC)-Control

Label is not available on this site.

06/11/1985 SUPPL-16 Labeling

Label is not available on this site.

06/27/1985 SUPPL-15 Manufacturing (CMC)-Formulation

Label is not available on this site.

12/11/1984 SUPPL-14 Manufacturing (CMC)-Packaging

Label is not available on this site.

05/01/1984 SUPPL-12 Labeling

Label is not available on this site.

06/02/1982 SUPPL-10 Manufacturing (CMC)-Control

Label is not available on this site.

03/25/1982 SUPPL-9 Manufacturing (CMC)-Packaging

Label is not available on this site.

06/26/1981 SUPPL-8 Manufacturing (CMC)

Label is not available on this site.

07/24/1981 SUPPL-7 Manufacturing (CMC)-Packaging

Label is not available on this site.

11/20/1979 SUPPL-5 Labeling

Label is not available on this site.

09/17/1979 SUPPL-4 Manufacturing (CMC)-Packaging

Label is not available on this site.

06/14/1979 SUPPL-3 Manufacturing (CMC)

Label is not available on this site.

02/18/1982 SUPPL-2 Efficacy

Label is not available on this site.

06/29/1978 SUPPL-1 Efficacy

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
07/28/2014 SUPPL-63 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/018013s063lbl.pdf
07/10/2014 SUPPL-62 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/018013s062lbl.pdf
10/26/2012 SUPPL-61 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/018012s029,018013s061lbl.pdf
07/13/2007 SUPPL-58 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/018013s58lbl.pdf
01/12/2005 SUPPL-56 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/18012s026,18013s056lbl.pdf

PAMELOR

CAPSULE;ORAL; EQ 10MG BASE
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
NORTRIPTYLINE HYDROCHLORIDE NORTRIPTYLINE HYDROCHLORIDE EQ 10MG BASE CAPSULE;ORAL Prescription No AB 073553 MAYNE PHARMA
NORTRIPTYLINE HYDROCHLORIDE NORTRIPTYLINE HYDROCHLORIDE EQ 10MG BASE CAPSULE;ORAL Prescription No AB 075520 TARO PHARM
NORTRIPTYLINE HYDROCHLORIDE NORTRIPTYLINE HYDROCHLORIDE EQ 10MG BASE CAPSULE;ORAL Prescription No AB 074132 TEVA
PAMELOR NORTRIPTYLINE HYDROCHLORIDE EQ 10MG BASE CAPSULE;ORAL Prescription Yes AB 018013 MALLINCKRODT LLC

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

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
NORTRIPTYLINE HYDROCHLORIDE NORTRIPTYLINE HYDROCHLORIDE EQ 25MG BASE CAPSULE;ORAL Prescription No AB 073554 MAYNE PHARMA
NORTRIPTYLINE HYDROCHLORIDE NORTRIPTYLINE HYDROCHLORIDE EQ 25MG BASE CAPSULE;ORAL Prescription No AB 075520 TARO PHARM
NORTRIPTYLINE HYDROCHLORIDE NORTRIPTYLINE HYDROCHLORIDE EQ 25MG BASE CAPSULE;ORAL Prescription No AB 074132 TEVA
PAMELOR NORTRIPTYLINE HYDROCHLORIDE EQ 25MG BASE CAPSULE;ORAL Prescription Yes AB 018013 MALLINCKRODT LLC

CAPSULE;ORAL; EQ 75MG BASE
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
NORTRIPTYLINE HYDROCHLORIDE NORTRIPTYLINE HYDROCHLORIDE EQ 75MG BASE CAPSULE;ORAL Prescription No AB 073556 MAYNE PHARMA
NORTRIPTYLINE HYDROCHLORIDE NORTRIPTYLINE HYDROCHLORIDE EQ 75MG BASE CAPSULE;ORAL Prescription No AB 075520 TARO PHARM
NORTRIPTYLINE HYDROCHLORIDE NORTRIPTYLINE HYDROCHLORIDE EQ 75MG BASE CAPSULE;ORAL Prescription No AB 074132 TEVA
PAMELOR NORTRIPTYLINE HYDROCHLORIDE EQ 75MG BASE CAPSULE;ORAL Prescription Yes AB 018013 MALLINCKRODT LLC

CAPSULE;ORAL; EQ 50MG BASE
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
NORTRIPTYLINE HYDROCHLORIDE NORTRIPTYLINE HYDROCHLORIDE EQ 50MG BASE CAPSULE;ORAL Prescription No AB 073555 MAYNE PHARMA
NORTRIPTYLINE HYDROCHLORIDE NORTRIPTYLINE HYDROCHLORIDE EQ 50MG BASE CAPSULE;ORAL Prescription No AB 075520 TARO PHARM
NORTRIPTYLINE HYDROCHLORIDE NORTRIPTYLINE HYDROCHLORIDE EQ 50MG BASE CAPSULE;ORAL Prescription No AB 074132 TEVA
PAMELOR NORTRIPTYLINE HYDROCHLORIDE EQ 50MG BASE CAPSULE;ORAL Prescription Yes AB 018013 MALLINCKRODT LLC

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