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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 075998
Company: SUN PHARM INDUSTRIES

Products on ANDA 075998

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 075998

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
11/29/2001	ORIG-1	Approval			Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/75998APltrF.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
10/31/2019	SUPPL-20	Labeling-Patient Package Insert, Labeling-Package Insert		Label is not available on this site.
10/24/2003	SUPPL-5	Labeling		Label is not available on this site.
06/18/2002	SUPPL-1	Manufacturing (CMC)-Control		Label is not available on this site.

Therapeutic Equivalents for ANDA 075998

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

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