Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 088292
Company: PAR PHARM
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
IMIPRAMINE HYDROCHLORIDE IMIPRAMINE HYDROCHLORIDE 10MG 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
10/21/1983 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
09/11/2014 SUPPL-34 Labeling-Package Insert

Label is not available on this site.

02/20/2008 SUPPL-32 Labeling

Label is not available on this site.

06/25/2007 SUPPL-30 Labeling

Label is not available on this site.

09/12/2005 SUPPL-29 Labeling

Label is not available on this site.

05/10/2005 SUPPL-28 Labeling

Label is not available on this site.

05/05/2005 SUPPL-27 Labeling

Label is not available on this site.

05/09/2003 SUPPL-26 Labeling

Label is not available on this site.

08/27/1999 SUPPL-23 Labeling

Label is not available on this site.

10/02/1997 SUPPL-22 Manufacturing (CMC)

Label is not available on this site.

03/25/1996 SUPPL-21 Manufacturing (CMC)

Label is not available on this site.

03/25/1996 SUPPL-20 Manufacturing (CMC)

Label is not available on this site.

03/25/1996 SUPPL-19 Labeling

Label is not available on this site.

11/16/1995 SUPPL-18 Labeling

Label is not available on this site.

11/10/1993 SUPPL-17 Labeling

Label is not available on this site.

01/07/1991 SUPPL-16 Labeling

Label is not available on this site.

06/17/1986 SUPPL-14 Manufacturing (CMC)

Label is not available on this site.

06/17/1986 SUPPL-13 Manufacturing (CMC)

Label is not available on this site.

06/29/1984 SUPPL-9 Manufacturing (CMC)

Label is not available on this site.

02/10/1984 SUPPL-8 Manufacturing (CMC)

Label is not available on this site.

04/02/1984 SUPPL-6 Manufacturing (CMC)

Label is not available on this site.

04/02/1984 SUPPL-5 Manufacturing (CMC)

Label is not available on this site.

12/16/1983 SUPPL-3 Manufacturing (CMC)

Label is not available on this site.

12/16/1983 SUPPL-2 Manufacturing (CMC)

Label is not available on this site.

12/16/1983 SUPPL-1 Manufacturing (CMC)

Label is not available on this site.

IMIPRAMINE HYDROCHLORIDE

TABLET;ORAL; 10MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
IMIPRAMINE HYDROCHLORIDE IMIPRAMINE HYDROCHLORIDE 10MG TABLET;ORAL Prescription No AB 040903 LEADING PHARMA LLC
IMIPRAMINE HYDROCHLORIDE IMIPRAMINE HYDROCHLORIDE 10MG TABLET;ORAL Prescription No AB 090441 LUPIN LTD
IMIPRAMINE HYDROCHLORIDE IMIPRAMINE HYDROCHLORIDE 10MG TABLET;ORAL Prescription No AB 088292 PAR PHARM
IMIPRAMINE HYDROCHLORIDE IMIPRAMINE HYDROCHLORIDE 10MG TABLET;ORAL Prescription No AB 084936 SANDOZ
IMIPRAMINE HYDROCHLORIDE IMIPRAMINE HYDROCHLORIDE 10MG TABLET;ORAL Prescription No AB 087846 SPECGX LLC
IMIPRAMINE HYDROCHLORIDE IMIPRAMINE HYDROCHLORIDE 10MG TABLET;ORAL Prescription No AB 081048 SUN PHARM INDUSTRIES
TOFRANIL IMIPRAMINE HYDROCHLORIDE 10MG TABLET;ORAL Prescription No AB 087844 MALLINCKRODT INC

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