Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 081048
Company: SUN PHARM INDUSTRIES
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
06/05/1990 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-33 Labeling-Package Insert

Label is not available on this site.

09/11/2014 SUPPL-31 Labeling-Patient Package Insert

Label is not available on this site.

10/19/2007 SUPPL-28 Labeling

Label is not available on this site.

10/19/2007 SUPPL-27 Labeling

Label is not available on this site.

06/26/2007 SUPPL-26 Labeling

Label is not available on this site.

12/02/2005 SUPPL-22 Labeling

Label is not available on this site.

05/05/2005 SUPPL-21 Labeling

Label is not available on this site.

04/02/2001 SUPPL-12 Manufacturing (CMC)-Control

Label is not available on this site.

10/02/2000 SUPPL-11 Labeling

Label is not available on this site.

10/02/2000 SUPPL-10 Manufacturing (CMC)-Packaging

Label is not available on this site.

05/16/2000 SUPPL-9 Manufacturing (CMC)-Facility

Label is not available on this site.

05/16/2000 SUPPL-8 Manufacturing (CMC)-Facility

Label is not available on this site.

05/26/1999 SUPPL-7 Labeling

Label is not available on this site.

12/05/1997 SUPPL-6 Manufacturing (CMC)

Label is not available on this site.

02/24/1997 SUPPL-5 Manufacturing (CMC)

Label is not available on this site.

11/09/1995 SUPPL-4 Labeling

Label is not available on this site.

06/22/1995 SUPPL-3 Manufacturing (CMC)

Label is not available on this site.

01/12/1994 SUPPL-2 Manufacturing (CMC)

Label is not available on this site.

07/30/1993 SUPPL-1 Labeling

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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