Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 087844
Company: MALLINCKRODT INC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
TOFRANIL 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
05/22/1984 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
06/29/2017 SUPPL-28 Labeling-Package Insert

Label is not available on this site.

07/17/2014 SUPPL-27 Labeling-Medication Guide, Labeling-Package Insert

Label is not available on this site.

09/27/2007 SUPPL-25 Labeling

Label is not available on this site.

06/25/2007 SUPPL-24 Labeling

Label is not available on this site.

09/12/2005 SUPPL-22 Labeling

Label is not available on this site.

06/09/2005 SUPPL-21 Labeling

Label is not available on this site.

08/31/2004 SUPPL-20 Labeling

Label is not available on this site.

09/01/1998 SUPPL-14 Labeling

Label is not available on this site.

12/20/1994 SUPPL-12 Labeling

Label is not available on this site.

02/02/1993 SUPPL-10 Labeling

Label is not available on this site.

TOFRANIL

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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