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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 075938
Company: STRIDES PHARMA INTL

Products on ANDA 075938

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
PROPAFENONE HYDROCHLORIDE	PROPAFENONE HYDROCHLORIDE	150MG	TABLET;ORAL	Prescription	AB	No	No
PROPAFENONE HYDROCHLORIDE	PROPAFENONE HYDROCHLORIDE	225MG	TABLET;ORAL	Prescription	AB	No	No
PROPAFENONE HYDROCHLORIDE	PROPAFENONE HYDROCHLORIDE	300MG	TABLET;ORAL	Prescription	AB	No	Yes

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 075938

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
10/17/2002	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
10/17/2024	SUPPL-23	Labeling-Patient Package Insert, Labeling-Container/Carton Labels, Labeling, Labeling-Package Insert		Label is not available on this site.
10/17/2024	SUPPL-19	Labeling-Patient Package Insert, Labeling-Package Insert		Label is not available on this site.
05/29/2016	SUPPL-14	Labeling-Package Insert		Label is not available on this site.
08/27/2015	SUPPL-11	Labeling-Package Insert		Label is not available on this site.
05/04/2006	SUPPL-4	Labeling		Label is not available on this site.

Therapeutic Equivalents for ANDA 075938

PROPAFENONE HYDROCHLORIDE

TABLET;ORAL; 150MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
PROPAFENONE HYDROCHLORIDE	PROPAFENONE HYDROCHLORIDE	150MG	TABLET;ORAL	Prescription	No	AB	076550	ANI PHARMS
PROPAFENONE HYDROCHLORIDE	PROPAFENONE HYDROCHLORIDE	150MG	TABLET;ORAL	Prescription	No	AB	202445	AUROBINDO PHARMA
PROPAFENONE HYDROCHLORIDE	PROPAFENONE HYDROCHLORIDE	150MG	TABLET;ORAL	Prescription	No	AB	075938	STRIDES PHARMA INTL
PROPAFENONE HYDROCHLORIDE	PROPAFENONE HYDROCHLORIDE	150MG	TABLET;ORAL	Prescription	No	AB	075203	WATSON LABS

TABLET;ORAL; 225MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
PROPAFENONE HYDROCHLORIDE	PROPAFENONE HYDROCHLORIDE	225MG	TABLET;ORAL	Prescription	No	AB	076550	ANI PHARMS
PROPAFENONE HYDROCHLORIDE	PROPAFENONE HYDROCHLORIDE	225MG	TABLET;ORAL	Prescription	No	AB	202445	AUROBINDO PHARMA
PROPAFENONE HYDROCHLORIDE	PROPAFENONE HYDROCHLORIDE	225MG	TABLET;ORAL	Prescription	No	AB	075938	STRIDES PHARMA INTL
PROPAFENONE HYDROCHLORIDE	PROPAFENONE HYDROCHLORIDE	225MG	TABLET;ORAL	Prescription	No	AB	075203	WATSON LABS

TABLET;ORAL; 300MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
PROPAFENONE HYDROCHLORIDE	PROPAFENONE HYDROCHLORIDE	300MG	TABLET;ORAL	Prescription	No	AB	076550	ANI PHARMS
PROPAFENONE HYDROCHLORIDE	PROPAFENONE HYDROCHLORIDE	300MG	TABLET;ORAL	Prescription	No	AB	202445	AUROBINDO PHARMA
PROPAFENONE HYDROCHLORIDE	PROPAFENONE HYDROCHLORIDE	300MG	TABLET;ORAL	Prescription	No	AB	075938	STRIDES PHARMA INTL

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