An official website of the United States government Here's how you know

The .gov means it's official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you're on a federal government site.

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

Abbreviated New Drug Application (ANDA): 202445
Company: AUROBINDO PHARMA

Products on ANDA 202445

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	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 202445

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
05/11/2016	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
11/13/2019	SUPPL-1	Labeling-Package Insert, Labeling-Container/Carton Labels		Label is not available on this site.

Therapeutic Equivalents for ANDA 202445

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
PROPAFENONE HYDROCHLORIDE	PROPAFENONE HYDROCHLORIDE	150MG	TABLET;ORAL	Prescription	No	AB	075998	SUN PHARM INDUSTRIES
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
PROPAFENONE HYDROCHLORIDE	PROPAFENONE HYDROCHLORIDE	225MG	TABLET;ORAL	Prescription	No	AB	075998	SUN PHARM INDUSTRIES
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
PROPAFENONE HYDROCHLORIDE	PROPAFENONE HYDROCHLORIDE	300MG	TABLET;ORAL	Prescription	No	AB	075998	SUN PHARM INDUSTRIES

Top