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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 075203
Company: WATSON LABS

Products on ANDA 075203

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

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 075203

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
10/24/2000	ORIG-1	Approval			Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/anda/2000/75203_Propafenone%20Hydrochloride_Prntlbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/75203ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/anda/2000/075203_propafenone-hydrochloride_toc.cfm

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
11/13/2019	SUPPL-17	Labeling-Package Insert, Labeling-Patient Package Insert		Label is not available on this site.
08/13/2015	SUPPL-15	Labeling-Package Insert		Label is not available on this site.
08/13/2015	SUPPL-12	Labeling-Package Insert		Label is not available on this site.
09/24/2003	SUPPL-5	Labeling		Label is not available on this site.
11/07/2002	SUPPL-3	Manufacturing (CMC)-Facility		Label is not available on this site.
05/24/2002	SUPPL-2	Labeling		Label is not available on this site.
02/19/2002	SUPPL-1	Manufacturing (CMC)-Control		Label is not available on this site.

Labels for ANDA 075203

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
10/24/2000	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/anda/2000/75203_Propafenone%20Hydrochloride_Prntlbl.pdf

Therapeutic Equivalents for ANDA 075203

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

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