Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 040903
Company: LEADING PHARMA LLC
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
IMIPRAMINE HYDROCHLORIDE IMIPRAMINE HYDROCHLORIDE 25MG TABLET;ORAL Prescription AB No No
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
10/24/2012 ORIG-1 Approval Label (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/040903lbl.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
11/17/2014 SUPPL-4 Labeling-Package Insert

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
10/24/2012 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/040903lbl.pdf

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

TABLET;ORAL; 25MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
IMIPRAMINE HYDROCHLORIDE IMIPRAMINE HYDROCHLORIDE 25MG TABLET;ORAL Prescription No AB 040903 LEADING PHARMA LLC
IMIPRAMINE HYDROCHLORIDE IMIPRAMINE HYDROCHLORIDE 25MG TABLET;ORAL Prescription No AB 090441 LUPIN LTD
IMIPRAMINE HYDROCHLORIDE IMIPRAMINE HYDROCHLORIDE 25MG TABLET;ORAL Prescription No AB 088262 PAR PHARM
IMIPRAMINE HYDROCHLORIDE IMIPRAMINE HYDROCHLORIDE 25MG TABLET;ORAL Prescription No AB 083745 SANDOZ
IMIPRAMINE HYDROCHLORIDE IMIPRAMINE HYDROCHLORIDE 25MG TABLET;ORAL Prescription No AB 087846 SPECGX LLC
IMIPRAMINE HYDROCHLORIDE IMIPRAMINE HYDROCHLORIDE 25MG TABLET;ORAL Prescription No AB 081049 SUN PHARM INDUSTRIES
TOFRANIL IMIPRAMINE HYDROCHLORIDE 25MG TABLET;ORAL Prescription No AB 087845 MALLINCKRODT INC

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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