Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 019906
Company: MALLINCKRODT LLC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
ANAFRANIL CLOMIPRAMINE HYDROCHLORIDE 25MG CAPSULE;ORAL Prescription AB Yes Yes
ANAFRANIL CLOMIPRAMINE HYDROCHLORIDE 50MG CAPSULE;ORAL Prescription AB Yes No
ANAFRANIL CLOMIPRAMINE HYDROCHLORIDE 75MG 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
12/29/1989 ORIG-1 Approval Type 1 - New Molecular Entity PRIORITY

Label is not available on this site.

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
05/24/2017 SUPPL-40 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/019906s040lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/019906Orig1s040ltr.pdf
07/28/2014 SUPPL-39 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/019906s039lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/018012Orig1s031,018013Orig1s063,017090Orig1s078,019906Orig1s039ltr.pdf
07/10/2014 SUPPL-38 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/019906s038lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/018012Orig1s030,018013Orig1s062,017090Orig1s077,019906Orig1s038ltr.pdf
10/26/2012 SUPPL-37 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/019906s037lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/019906Orig1s037,018012Orig1029,018013Orig1s061,017090Orig1s076ltr.pdf
07/13/2007 SUPPL-34 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/019906s34lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/017090s74,18012s27,18013s58,19906s34ltr.pdf
01/12/2005 SUPPL-32 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/019906s032lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/019906s032ltr.pdf
09/03/2004 SUPPL-30 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/19906s030ltr.pdf
06/20/2002 SUPPL-28 Manufacturing (CMC)

Label is not available on this site.

03/23/2001 SUPPL-27 Manufacturing (CMC)-Control

Label is not available on this site.

10/31/2000 SUPPL-26 Manufacturing (CMC)

Label is not available on this site.

07/03/2000 SUPPL-25 Manufacturing (CMC)

Label is not available on this site.

04/15/1999 SUPPL-24 Manufacturing (CMC)-Packaging

Label is not available on this site.

03/08/1999 SUPPL-23 Manufacturing (CMC)

Label is not available on this site.

01/04/1999 SUPPL-22 Labeling Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/99/019906_S022_ANAFRANIL_AP.pdf
05/18/1998 SUPPL-21 Manufacturing (CMC)-Control

Label is not available on this site.

01/15/1998 SUPPL-20 Labeling

Label is not available on this site.

04/02/1997 SUPPL-19 Labeling

Label is not available on this site.

02/11/1997 SUPPL-18 Manufacturing (CMC)-Control

Label is not available on this site.

04/02/1997 SUPPL-17 Labeling

Label is not available on this site.

11/22/1995 SUPPL-16 Manufacturing (CMC)

Label is not available on this site.

12/14/1995 SUPPL-15 Manufacturing (CMC)-Control

Label is not available on this site.

10/20/1995 SUPPL-14 Manufacturing (CMC)

Label is not available on this site.

10/05/1995 SUPPL-13 Manufacturing (CMC)-Control

Label is not available on this site.

04/13/1994 SUPPL-12 Labeling

Label is not available on this site.

07/13/1994 SUPPL-11 Manufacturing (CMC)-Control

Label is not available on this site.

07/01/1994 SUPPL-10 Manufacturing (CMC)-Control

Label is not available on this site.

07/31/2001 SUPPL-9 Labeling Label (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2001/19906s9lbl.pdf
04/13/1994 SUPPL-8 Labeling

Label is not available on this site.

04/09/1991 SUPPL-7 Labeling

Label is not available on this site.

05/15/1991 SUPPL-6 Manufacturing (CMC)-Control

Label is not available on this site.

04/09/1991 SUPPL-5 Labeling

Label is not available on this site.

01/31/1991 SUPPL-4 Manufacturing (CMC)-Formulation

Label is not available on this site.

04/09/1991 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
05/24/2017 SUPPL-40 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/019906s040lbl.pdf
07/28/2014 SUPPL-39 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/019906s039lbl.pdf
07/10/2014 SUPPL-38 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/019906s038lbl.pdf
10/26/2012 SUPPL-37 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/019906s037lbl.pdf
07/13/2007 SUPPL-34 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/019906s34lbl.pdf
01/12/2005 SUPPL-32 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/019906s032lbl.pdf
07/31/2001 SUPPL-9 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2001/19906s9lbl.pdf

ANAFRANIL

CAPSULE;ORAL; 25MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
ANAFRANIL CLOMIPRAMINE HYDROCHLORIDE 25MG CAPSULE;ORAL Prescription Yes AB 019906 MALLINCKRODT LLC
CLOMIPRAMINE HYDROCHLORIDE CLOMIPRAMINE HYDROCHLORIDE 25MG CAPSULE;ORAL Prescription No AB 074947 MYLAN
CLOMIPRAMINE HYDROCHLORIDE CLOMIPRAMINE HYDROCHLORIDE 25MG CAPSULE;ORAL Prescription No AB 074364 SANDOZ
CLOMIPRAMINE HYDROCHLORIDE CLOMIPRAMINE HYDROCHLORIDE 25MG CAPSULE;ORAL Prescription No AB 074953 SANDOZ
CLOMIPRAMINE HYDROCHLORIDE CLOMIPRAMINE HYDROCHLORIDE 25MG CAPSULE;ORAL Prescription No AB 074694 TARO
CLOMIPRAMINE HYDROCHLORIDE CLOMIPRAMINE HYDROCHLORIDE 25MG CAPSULE;ORAL Prescription No AB 074958 TEVA

CAPSULE;ORAL; 50MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
ANAFRANIL CLOMIPRAMINE HYDROCHLORIDE 50MG CAPSULE;ORAL Prescription Yes AB 019906 MALLINCKRODT LLC
CLOMIPRAMINE HYDROCHLORIDE CLOMIPRAMINE HYDROCHLORIDE 50MG CAPSULE;ORAL Prescription No AB 074947 MYLAN
CLOMIPRAMINE HYDROCHLORIDE CLOMIPRAMINE HYDROCHLORIDE 50MG CAPSULE;ORAL Prescription No AB 074364 SANDOZ
CLOMIPRAMINE HYDROCHLORIDE CLOMIPRAMINE HYDROCHLORIDE 50MG CAPSULE;ORAL Prescription No AB 074953 SANDOZ
CLOMIPRAMINE HYDROCHLORIDE CLOMIPRAMINE HYDROCHLORIDE 50MG CAPSULE;ORAL Prescription No AB 074694 TARO
CLOMIPRAMINE HYDROCHLORIDE CLOMIPRAMINE HYDROCHLORIDE 50MG CAPSULE;ORAL Prescription No AB 074958 TEVA

CAPSULE;ORAL; 75MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
ANAFRANIL CLOMIPRAMINE HYDROCHLORIDE 75MG CAPSULE;ORAL Prescription Yes AB 019906 MALLINCKRODT LLC
CLOMIPRAMINE HYDROCHLORIDE CLOMIPRAMINE HYDROCHLORIDE 75MG CAPSULE;ORAL Prescription No AB 074947 MYLAN
CLOMIPRAMINE HYDROCHLORIDE CLOMIPRAMINE HYDROCHLORIDE 75MG CAPSULE;ORAL Prescription No AB 074364 SANDOZ
CLOMIPRAMINE HYDROCHLORIDE CLOMIPRAMINE HYDROCHLORIDE 75MG CAPSULE;ORAL Prescription No AB 074953 SANDOZ
CLOMIPRAMINE HYDROCHLORIDE CLOMIPRAMINE HYDROCHLORIDE 75MG CAPSULE;ORAL Prescription No AB 074694 TARO
CLOMIPRAMINE HYDROCHLORIDE CLOMIPRAMINE HYDROCHLORIDE 75MG CAPSULE;ORAL Prescription No AB 074958 TEVA

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