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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 040751
Company: OXFORD PHARMS

Safety Labeling Change Order Letter

Products on ANDA 040751

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
IMIPRAMINE HYDROCHLORIDE	IMIPRAMINE HYDROCHLORIDE	50MG	TABLET;ORAL	Prescription	AB	No	No
IMIPRAMINE HYDROCHLORIDE	IMIPRAMINE HYDROCHLORIDE	25MG	TABLET;ORAL	Prescription	AB	No	No
IMIPRAMINE HYDROCHLORIDE	IMIPRAMINE HYDROCHLORIDE	10MG	TABLET;ORAL	Prescription	AB	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 040751

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
02/28/2008	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
06/24/2025	SUPPL-7	Labeling-Package Insert		Label is not available on this site.
12/20/2024	SUPPL-2	Labeling-Package Insert		Label is not available on this site.
11/17/2014	SUPPL-1	Labeling-Medication Guide		Label is not available on this site.

Therapeutic Equivalents for ANDA 040751

IMIPRAMINE HYDROCHLORIDE

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 INTL
IMIPRAMINE HYDROCHLORIDE	IMIPRAMINE HYDROCHLORIDE	50MG	TABLET;ORAL	Prescription	No	AB	081050	SUN PHARM INDUSTRIES

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 INTL
IMIPRAMINE HYDROCHLORIDE	IMIPRAMINE HYDROCHLORIDE	25MG	TABLET;ORAL	Prescription	No	AB	081049	SUN PHARM INDUSTRIES

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 INTL

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