Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 074958
Company: TEVA

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
CLOMIPRAMINE HYDROCHLORIDE CLOMIPRAMINE HYDROCHLORIDE 25MG CAPSULE;ORAL Discontinued None No No
CLOMIPRAMINE HYDROCHLORIDE CLOMIPRAMINE HYDROCHLORIDE 50MG CAPSULE;ORAL Discontinued None No No
CLOMIPRAMINE HYDROCHLORIDE CLOMIPRAMINE HYDROCHLORIDE 75MG CAPSULE;ORAL Discontinued None 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
08/26/1997 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
09/14/2007 SUPPL-15 Labeling

Label is not available on this site.
06/29/2007 SUPPL-14 Labeling

Label is not available on this site.
08/15/2005 SUPPL-13 Labeling

Label is not available on this site.
04/14/2005 SUPPL-12 Labeling

Label is not available on this site.
10/11/2002 SUPPL-10 Labeling

Label is not available on this site.
04/24/2002 SUPPL-9 Labeling

Label is not available on this site.
04/24/2002 SUPPL-8 Labeling

Label is not available on this site.
12/02/1999 SUPPL-7 Manufacturing (CMC)-Facility

Label is not available on this site.
12/02/1999 SUPPL-6 Manufacturing (CMC)-Facility

Label is not available on this site.
02/12/1999 SUPPL-2 Manufacturing (CMC)

Label is not available on this site.
02/12/1999 SUPPL-1 Manufacturing (CMC)

Label is not available on this site.

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