Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 017090
Company: MALLINCKRODT INC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
TOFRANIL-PM IMIPRAMINE PAMOATE EQ 75MG HCL **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** CAPSULE;ORAL Discontinued None Yes No
TOFRANIL-PM IMIPRAMINE PAMOATE EQ 150MG HCL **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** CAPSULE;ORAL Discontinued None Yes No
TOFRANIL-PM IMIPRAMINE PAMOATE EQ 125MG HCL **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** CAPSULE;ORAL Discontinued None Yes No
TOFRANIL-PM IMIPRAMINE PAMOATE EQ 100MG HCL **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** CAPSULE;ORAL Discontinued None Yes No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
03/11/1973 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
07/28/2014 SUPPL-78 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/017090s078lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/018012Orig1s031,018013Orig1s063,017090Orig1s078,019906Orig1s039ltr.pdf
07/10/2014 SUPPL-77 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/017090s077lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/018012Orig1s030,018013Orig1s062,017090Orig1s077,019906Orig1s038ltr.pdf
10/26/2012 SUPPL-76 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/017090s076lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/019906Orig1s037,018012Orig1029,018013Orig1s061,017090Orig1s076ltr.pdf
07/13/2007 SUPPL-74 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/017090s74lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/017090s74,18012s27,18013s58,19906s34ltr.pdf
01/12/2005 SUPPL-70 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/17090s070lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/17090s070ltr.pdf
03/26/2004 SUPPL-69 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/17090slr069ltr.pdf
06/20/2002 SUPPL-68 Manufacturing (CMC)

Label is not available on this site.

01/03/2002 SUPPL-67 Labeling

Label is not available on this site.

06/21/2000 SUPPL-66 Manufacturing (CMC)

Label is not available on this site.

04/26/2000 SUPPL-65 Manufacturing (CMC)-Control

Label is not available on this site.

04/15/1999 SUPPL-64 Manufacturing (CMC)-Packaging

Label is not available on this site.

07/31/1997 SUPPL-63 Manufacturing (CMC)-Control

Label is not available on this site.

03/27/2000 SUPPL-62 Labeling

Label is not available on this site.

03/27/2000 SUPPL-61 Labeling

Label is not available on this site.

03/27/2000 SUPPL-60 Labeling

Label is not available on this site.

02/19/1993 SUPPL-59 Manufacturing (CMC)-Control

Label is not available on this site.

12/08/1992 SUPPL-58 Labeling

Label is not available on this site.

08/02/1991 SUPPL-57 Manufacturing (CMC)-Control

Label is not available on this site.

04/05/1990 SUPPL-56 Manufacturing (CMC)-Packaging

Label is not available on this site.

10/25/1989 SUPPL-55 Manufacturing (CMC)

Label is not available on this site.

10/25/1989 SUPPL-54 Manufacturing (CMC)

Label is not available on this site.

08/08/1989 SUPPL-53 Manufacturing (CMC)

Label is not available on this site.

04/07/1989 SUPPL-52 Manufacturing (CMC)-Packaging

Label is not available on this site.

08/12/1987 SUPPL-51 Efficacy-New Dosing Regimen

Label is not available on this site.

05/20/1986 SUPPL-50 Manufacturing (CMC)-Control

Label is not available on this site.

11/27/1985 SUPPL-49 Labeling

Label is not available on this site.

05/05/1985 SUPPL-48 Manufacturing (CMC)-Control

Label is not available on this site.

04/26/1985 SUPPL-47 Labeling

Label is not available on this site.

10/29/1984 SUPPL-46 Manufacturing (CMC)-Control

Label is not available on this site.

03/26/1984 SUPPL-45 Labeling

Label is not available on this site.

11/05/1984 SUPPL-44 Manufacturing (CMC)-Control

Label is not available on this site.

05/04/1983 SUPPL-42 Manufacturing (CMC)-Packaging

Label is not available on this site.

07/18/1986 SUPPL-41 Manufacturing (CMC)-Expiration Date

Label is not available on this site.

02/04/1981 SUPPL-40 Labeling

Label is not available on this site.

04/16/1980 SUPPL-39 Manufacturing (CMC)

Label is not available on this site.

04/16/1980 SUPPL-38 Manufacturing (CMC)-Packaging

Label is not available on this site.

01/30/1980 SUPPL-37 Manufacturing (CMC)-Packaging

Label is not available on this site.

06/07/1979 SUPPL-36 Manufacturing (CMC)-Packaging

Label is not available on this site.

06/07/1979 SUPPL-35 Manufacturing (CMC)

Label is not available on this site.

12/28/1979 SUPPL-34 Manufacturing (CMC)-Control

Label is not available on this site.

12/28/1979 SUPPL-33 Manufacturing (CMC)-Control

Label is not available on this site.

01/02/1979 SUPPL-32 Labeling

Label is not available on this site.

06/07/1977 SUPPL-25 Manufacturing (CMC)-Control

Label is not available on this site.

12/03/1975 SUPPL-23 Manufacturing (CMC)-Control

Label is not available on this site.

06/03/1974 SUPPL-19 Manufacturing (CMC)-Control

Label is not available on this site.

05/28/1974 SUPPL-17 Manufacturing (CMC)-Control

Label is not available on this site.

05/28/1974 SUPPL-16 Manufacturing (CMC)-Control

Label is not available on this site.

05/28/1974 SUPPL-15 Manufacturing (CMC)-Control

Label is not available on this site.

05/28/1974 SUPPL-14 Manufacturing (CMC)-Control

Label is not available on this site.

05/28/1974 SUPPL-13 Manufacturing (CMC)-Control

Label is not available on this site.

05/28/1974 SUPPL-12 Manufacturing (CMC)-Control

Label is not available on this site.

05/22/1974 SUPPL-10 Unspecified

Label is not available on this site.

05/22/1974 SUPPL-9 Unspecified

Label is not available on this site.

05/22/1974 SUPPL-8 Unspecified

Label is not available on this site.

05/22/1974 SUPPL-7 Unspecified

Label is not available on this site.

05/22/1974 SUPPL-6 Unspecified

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-78 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/017090s078lbl.pdf
07/10/2014 SUPPL-77 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/017090s077lbl.pdf
10/26/2012 SUPPL-76 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/017090s076lbl.pdf
07/13/2007 SUPPL-74 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/017090s74lbl.pdf
01/12/2005 SUPPL-70 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/17090s070lbl.pdf

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