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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 075998
Company: SUN PHARM INDUSTRIES
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
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-Package Insert, Labeling-Patient 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.

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 LTD
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 LTD
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 LTD
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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