Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 074364
Company: SANDOZ
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
CLOMIPRAMINE HYDROCHLORIDE CLOMIPRAMINE HYDROCHLORIDE 25MG CAPSULE;ORAL Prescription AB No No
CLOMIPRAMINE HYDROCHLORIDE CLOMIPRAMINE HYDROCHLORIDE 50MG CAPSULE;ORAL Prescription AB No No
CLOMIPRAMINE HYDROCHLORIDE CLOMIPRAMINE HYDROCHLORIDE 75MG CAPSULE;ORAL Prescription AB No 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
03/29/1996 ORIG-1 Approval

Label is not available on this site.

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
03/18/2013 SUPPL-20 Labeling-Package Insert

Label is not available on this site.

09/14/2007 SUPPL-16 Labeling

Label is not available on this site.

06/29/2007 SUPPL-15 Labeling

Label is not available on this site.

09/29/2005 SUPPL-14 Labeling

Label is not available on this site.

04/14/2005 SUPPL-13 Labeling

Label is not available on this site.

04/19/2002 SUPPL-12 Manufacturing (CMC)-Control

Label is not available on this site.

11/06/2001 SUPPL-11 Manufacturing (CMC)-Control

Label is not available on this site.

10/09/2001 SUPPL-10 Manufacturing (CMC)-Control

Label is not available on this site.

03/22/2001 SUPPL-9 Labeling

Label is not available on this site.

11/30/2000 SUPPL-8 Manufacturing (CMC)-Control

Label is not available on this site.

04/10/2001 SUPPL-7 Manufacturing (CMC)-Control

Label is not available on this site.

10/31/2000 SUPPL-6 Manufacturing (CMC)-Control

Label is not available on this site.

07/25/2002 SUPPL-5 Manufacturing (CMC)

Label is not available on this site.

03/23/1999 SUPPL-4 Manufacturing (CMC)

Label is not available on this site.

02/09/1998 SUPPL-2 Labeling

Label is not available on this site.

06/10/1997 SUPPL-1 Manufacturing (CMC)

Label is not available on this site.

CLOMIPRAMINE HYDROCHLORIDE

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 SPECGX LLC
CLOMIPRAMINE HYDROCHLORIDE CLOMIPRAMINE HYDROCHLORIDE 25MG CAPSULE;ORAL Prescription No AB 208632 AMNEAL PHARMS CO
CLOMIPRAMINE HYDROCHLORIDE CLOMIPRAMINE HYDROCHLORIDE 25MG CAPSULE;ORAL Prescription No AB 212218 JUBILANT CADISTA
CLOMIPRAMINE HYDROCHLORIDE CLOMIPRAMINE HYDROCHLORIDE 25MG CAPSULE;ORAL Prescription No AB 209294 LUPIN LTD
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
CLOMIPRAMINE HYDROCHLORIDE CLOMIPRAMINE HYDROCHLORIDE 25MG CAPSULE;ORAL Prescription No AB 208961 ZYDUS PHARMS

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 SPECGX LLC
CLOMIPRAMINE HYDROCHLORIDE CLOMIPRAMINE HYDROCHLORIDE 50MG CAPSULE;ORAL Prescription No AB 208632 AMNEAL PHARMS CO
CLOMIPRAMINE HYDROCHLORIDE CLOMIPRAMINE HYDROCHLORIDE 50MG CAPSULE;ORAL Prescription No AB 212218 JUBILANT CADISTA
CLOMIPRAMINE HYDROCHLORIDE CLOMIPRAMINE HYDROCHLORIDE 50MG CAPSULE;ORAL Prescription No AB 209294 LUPIN LTD
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
CLOMIPRAMINE HYDROCHLORIDE CLOMIPRAMINE HYDROCHLORIDE 50MG CAPSULE;ORAL Prescription No AB 208961 ZYDUS PHARMS

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 SPECGX LLC
CLOMIPRAMINE HYDROCHLORIDE CLOMIPRAMINE HYDROCHLORIDE 75MG CAPSULE;ORAL Prescription No AB 208632 AMNEAL PHARMS CO
CLOMIPRAMINE HYDROCHLORIDE CLOMIPRAMINE HYDROCHLORIDE 75MG CAPSULE;ORAL Prescription No AB 212218 JUBILANT CADISTA
CLOMIPRAMINE HYDROCHLORIDE CLOMIPRAMINE HYDROCHLORIDE 75MG CAPSULE;ORAL Prescription No AB 209294 LUPIN LTD
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
CLOMIPRAMINE HYDROCHLORIDE CLOMIPRAMINE HYDROCHLORIDE 75MG CAPSULE;ORAL Prescription No AB 208961 ZYDUS PHARMS

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