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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 040903
Company: LEADING

Products on ANDA 040903

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	Yes

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 040903

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
10/06/2023	SUPPL-8	Labeling-Package Insert		Label is not available on this site.
11/17/2014	SUPPL-4	Labeling-Package Insert		Label is not available on this site.

Labels for ANDA 040903

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

Therapeutic Equivalents for ANDA 040903

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
IMIPRAMINE HYDROCHLORIDE	IMIPRAMINE HYDROCHLORIDE	10MG	TABLET;ORAL	Prescription	No	AB	040751	OXFORD PHARMS
IMIPRAMINE HYDROCHLORIDE	IMIPRAMINE HYDROCHLORIDE	10MG	TABLET;ORAL	Prescription	No	AB	084936	SANDOZ
IMIPRAMINE HYDROCHLORIDE	IMIPRAMINE HYDROCHLORIDE	10MG	TABLET;ORAL	Prescription	No	AB	088292	STRIDES PHARMA

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
IMIPRAMINE HYDROCHLORIDE	IMIPRAMINE HYDROCHLORIDE	25MG	TABLET;ORAL	Prescription	No	AB	040751	OXFORD PHARMS
IMIPRAMINE HYDROCHLORIDE	IMIPRAMINE HYDROCHLORIDE	25MG	TABLET;ORAL	Prescription	No	AB	083745	SANDOZ
IMIPRAMINE HYDROCHLORIDE	IMIPRAMINE HYDROCHLORIDE	25MG	TABLET;ORAL	Prescription	No	AB	088262	STRIDES PHARMA
IMIPRAMINE HYDROCHLORIDE	IMIPRAMINE HYDROCHLORIDE	25MG	TABLET;ORAL	Prescription	No	AB	081049	SUN PHARM INDUSTRIES

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
IMIPRAMINE HYDROCHLORIDE	IMIPRAMINE HYDROCHLORIDE	50MG	TABLET;ORAL	Prescription	No	AB	040751	OXFORD PHARMS
IMIPRAMINE HYDROCHLORIDE	IMIPRAMINE HYDROCHLORIDE	50MG	TABLET;ORAL	Prescription	No	AB	084937	SANDOZ
IMIPRAMINE HYDROCHLORIDE	IMIPRAMINE HYDROCHLORIDE	50MG	TABLET;ORAL	Prescription	No	AB	088276	STRIDES PHARMA
IMIPRAMINE HYDROCHLORIDE	IMIPRAMINE HYDROCHLORIDE	50MG	TABLET;ORAL	Prescription	No	AB	081050	SUN PHARM INDUSTRIES

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