Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 084937
Company: SANDOZ
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
IMIPRAMINE HYDROCHLORIDE IMIPRAMINE HYDROCHLORIDE 50MG TABLET;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
04/20/1976 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
02/02/2016 SUPPL-128 Labeling-Package Insert

Label is not available on this site.

07/17/2014 SUPPL-127 Labeling-Package Insert

Label is not available on this site.

03/10/2008 SUPPL-120 Labeling

Label is not available on this site.

06/25/2007 SUPPL-119 Labeling

Label is not available on this site.

06/15/2005 SUPPL-118 Labeling

Label is not available on this site.

04/19/2002 SUPPL-115 Manufacturing (CMC)-Control

Label is not available on this site.

05/09/2001 SUPPL-114 Manufacturing (CMC)-Control

Label is not available on this site.

10/16/2001 SUPPL-113 Manufacturing (CMC)-Control

Label is not available on this site.

10/31/2000 SUPPL-112 Manufacturing (CMC)-Control

Label is not available on this site.

05/11/1999 SUPPL-111 Labeling

Label is not available on this site.

05/05/1999 SUPPL-110 Manufacturing (CMC)

Label is not available on this site.

06/01/1999 SUPPL-108 Labeling

Label is not available on this site.

05/01/1999 SUPPL-107 Manufacturing (CMC)

Label is not available on this site.

02/09/2007 SUPPL-106 Labeling

Label is not available on this site.

03/21/1995 SUPPL-102 Labeling

Label is not available on this site.

04/06/1995 SUPPL-101 Manufacturing (CMC)

Label is not available on this site.

03/11/1994 SUPPL-100 Labeling

Label is not available on this site.

04/15/1991 SUPPL-99 Labeling

Label is not available on this site.

11/07/1989 SUPPL-98 Labeling

Label is not available on this site.

09/15/1989 SUPPL-97 Labeling

Label is not available on this site.

10/02/1990 SUPPL-96 Manufacturing (CMC)

Label is not available on this site.

02/22/1988 SUPPL-94 Manufacturing (CMC)

Label is not available on this site.

02/22/1988 SUPPL-93 Labeling

Label is not available on this site.

02/22/1988 SUPPL-92 Manufacturing (CMC)

Label is not available on this site.

02/22/1988 SUPPL-91 Manufacturing (CMC)

Label is not available on this site.

02/22/1988 SUPPL-90 Manufacturing (CMC)

Label is not available on this site.

02/22/1988 SUPPL-89 Manufacturing (CMC)

Label is not available on this site.

04/09/1987 SUPPL-87 Manufacturing (CMC)

Label is not available on this site.

07/30/1986 SUPPL-85 Manufacturing (CMC)

Label is not available on this site.

07/30/1986 SUPPL-82 Manufacturing (CMC)

Label is not available on this site.

07/30/1986 SUPPL-81 Manufacturing (CMC)

Label is not available on this site.

07/30/1986 SUPPL-80 Manufacturing (CMC)

Label is not available on this site.

01/16/1986 SUPPL-79 Manufacturing (CMC)

Label is not available on this site.

12/27/1985 SUPPL-78 Manufacturing (CMC)

Label is not available on this site.

10/21/1983 SUPPL-73 Manufacturing (CMC)

Label is not available on this site.

07/21/1983 SUPPL-71 Manufacturing (CMC)

Label is not available on this site.

12/10/1982 SUPPL-69 Manufacturing (CMC)

Label is not available on this site.

12/10/1982 SUPPL-68 Manufacturing (CMC)

Label is not available on this site.

06/09/1982 SUPPL-65 Manufacturing (CMC)

Label is not available on this site.

06/09/1982 SUPPL-64 Manufacturing (CMC)

Label is not available on this site.

IMIPRAMINE HYDROCHLORIDE

TABLET;ORAL; 50MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
IMIPRAMINE HYDROCHLORIDE IMIPRAMINE HYDROCHLORIDE 50MG TABLET;ORAL Prescription No AB 040903 LEADING PHARMA LLC
IMIPRAMINE HYDROCHLORIDE IMIPRAMINE HYDROCHLORIDE 50MG TABLET;ORAL Prescription No AB 090441 LUPIN LTD
IMIPRAMINE HYDROCHLORIDE IMIPRAMINE HYDROCHLORIDE 50MG TABLET;ORAL Prescription No AB 088276 PAR PHARM
IMIPRAMINE HYDROCHLORIDE IMIPRAMINE HYDROCHLORIDE 50MG TABLET;ORAL Prescription No AB 084937 SANDOZ
IMIPRAMINE HYDROCHLORIDE IMIPRAMINE HYDROCHLORIDE 50MG TABLET;ORAL Prescription No AB 081050 SUN PHARM INDUSTRIES
TOFRANIL IMIPRAMINE HYDROCHLORIDE 50MG TABLET;ORAL Prescription No AB 087846 SPECGX LLC

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