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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 205956
Company: RISING

Products on ANDA 205956

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
PROPAFENONE HYDROCHLORIDE	PROPAFENONE HYDROCHLORIDE	225MG	CAPSULE, EXTENDED RELEASE;ORAL	Prescription	AB	No	No
PROPAFENONE HYDROCHLORIDE	PROPAFENONE HYDROCHLORIDE	325MG	CAPSULE, EXTENDED RELEASE;ORAL	Prescription	AB	No	No
PROPAFENONE HYDROCHLORIDE	PROPAFENONE HYDROCHLORIDE	425MG	CAPSULE, EXTENDED RELEASE;ORAL	Prescription	AB	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 205956

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
07/02/2018	ORIG-1	Approval		STANDARD		Label is not available on this site.

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
11/14/2019	SUPPL-3	Labeling-Package Insert		Label is not available on this site.

Therapeutic Equivalents for ANDA 205956

PROPAFENONE HYDROCHLORIDE

CAPSULE, EXTENDED RELEASE;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	CAPSULE, EXTENDED RELEASE;ORAL	Prescription	No	AB	213096	AUROBINDO PHARMA LTD
PROPAFENONE HYDROCHLORIDE	PROPAFENONE HYDROCHLORIDE	225MG	CAPSULE, EXTENDED RELEASE;ORAL	Prescription	No	AB	205268	GLENMARK PHARMS LTD
PROPAFENONE HYDROCHLORIDE	PROPAFENONE HYDROCHLORIDE	225MG	CAPSULE, EXTENDED RELEASE;ORAL	Prescription	No	AB	205956	RISING
PROPAFENONE HYDROCHLORIDE	PROPAFENONE HYDROCHLORIDE	225MG	CAPSULE, EXTENDED RELEASE;ORAL	Prescription	No	AB	078540	STRIDES PHARMA
PROPAFENONE HYDROCHLORIDE	PROPAFENONE HYDROCHLORIDE	225MG	CAPSULE, EXTENDED RELEASE;ORAL	Prescription	No	AB	212928	TWI PHARMS
PROPAFENONE HYDROCHLORIDE	PROPAFENONE HYDROCHLORIDE	225MG	CAPSULE, EXTENDED RELEASE;ORAL	Prescription	No	AB	212744	UPSHER SMITH LABS
PROPAFENONE HYDROCHLORIDE	PROPAFENONE HYDROCHLORIDE	225MG	CAPSULE, EXTENDED RELEASE;ORAL	Prescription	No	AB	202688	WATSON LABS INC
PROPAFENONE HYDROCHLORIDE	PROPAFENONE HYDROCHLORIDE	225MG	CAPSULE, EXTENDED RELEASE;ORAL	Prescription	No	AB	214184	ZYDUS LIFESCIENCES

CAPSULE, EXTENDED RELEASE;ORAL; 325MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
PROPAFENONE HYDROCHLORIDE	PROPAFENONE HYDROCHLORIDE	325MG	CAPSULE, EXTENDED RELEASE;ORAL	Prescription	No	AB	213096	AUROBINDO PHARMA LTD
PROPAFENONE HYDROCHLORIDE	PROPAFENONE HYDROCHLORIDE	325MG	CAPSULE, EXTENDED RELEASE;ORAL	Prescription	No	AB	205268	GLENMARK PHARMS LTD
PROPAFENONE HYDROCHLORIDE	PROPAFENONE HYDROCHLORIDE	325MG	CAPSULE, EXTENDED RELEASE;ORAL	Prescription	No	AB	205956	RISING
PROPAFENONE HYDROCHLORIDE	PROPAFENONE HYDROCHLORIDE	325MG	CAPSULE, EXTENDED RELEASE;ORAL	Prescription	No	AB	078540	STRIDES PHARMA
PROPAFENONE HYDROCHLORIDE	PROPAFENONE HYDROCHLORIDE	325MG	CAPSULE, EXTENDED RELEASE;ORAL	Prescription	No	AB	212928	TWI PHARMS
PROPAFENONE HYDROCHLORIDE	PROPAFENONE HYDROCHLORIDE	325MG	CAPSULE, EXTENDED RELEASE;ORAL	Prescription	No	AB	212744	UPSHER SMITH LABS
PROPAFENONE HYDROCHLORIDE	PROPAFENONE HYDROCHLORIDE	325MG	CAPSULE, EXTENDED RELEASE;ORAL	Prescription	No	AB	202688	WATSON LABS INC
PROPAFENONE HYDROCHLORIDE	PROPAFENONE HYDROCHLORIDE	325MG	CAPSULE, EXTENDED RELEASE;ORAL	Prescription	No	AB	214184	ZYDUS LIFESCIENCES

CAPSULE, EXTENDED RELEASE;ORAL; 425MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
PROPAFENONE HYDROCHLORIDE	PROPAFENONE HYDROCHLORIDE	425MG	CAPSULE, EXTENDED RELEASE;ORAL	Prescription	No	AB	213096	AUROBINDO PHARMA LTD
PROPAFENONE HYDROCHLORIDE	PROPAFENONE HYDROCHLORIDE	425MG	CAPSULE, EXTENDED RELEASE;ORAL	Prescription	No	AB	205268	GLENMARK PHARMS LTD
PROPAFENONE HYDROCHLORIDE	PROPAFENONE HYDROCHLORIDE	425MG	CAPSULE, EXTENDED RELEASE;ORAL	Prescription	No	AB	205956	RISING
PROPAFENONE HYDROCHLORIDE	PROPAFENONE HYDROCHLORIDE	425MG	CAPSULE, EXTENDED RELEASE;ORAL	Prescription	No	AB	078540	STRIDES PHARMA
PROPAFENONE HYDROCHLORIDE	PROPAFENONE HYDROCHLORIDE	425MG	CAPSULE, EXTENDED RELEASE;ORAL	Prescription	No	AB	212928	TWI PHARMS
PROPAFENONE HYDROCHLORIDE	PROPAFENONE HYDROCHLORIDE	425MG	CAPSULE, EXTENDED RELEASE;ORAL	Prescription	No	AB	212744	UPSHER SMITH LABS
PROPAFENONE HYDROCHLORIDE	PROPAFENONE HYDROCHLORIDE	425MG	CAPSULE, EXTENDED RELEASE;ORAL	Prescription	No	AB	202688	WATSON LABS INC
PROPAFENONE HYDROCHLORIDE	PROPAFENONE HYDROCHLORIDE	425MG	CAPSULE, EXTENDED RELEASE;ORAL	Prescription	No	AB	214184	ZYDUS LIFESCIENCES

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