Drugs@FDA: FDA Approved Drug Products

Home | Previous Page

Abbreviated New Drug Application (ANDA): 202445
Company: AUROBINDO PHARMA LTD
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
05/11/2016 ORIG-1 Approval

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 INC
PROPAFENONE HYDROCHLORIDE PROPAFENONE HYDROCHLORIDE 150MG TABLET;ORAL Prescription No AB 202445 AUROBINDO PHARMA LTD
PROPAFENONE HYDROCHLORIDE PROPAFENONE HYDROCHLORIDE 150MG TABLET;ORAL Prescription No AB 075998 SUN PHARM INDUSTRIES
PROPAFENONE HYDROCHLORIDE PROPAFENONE HYDROCHLORIDE 150MG TABLET;ORAL Prescription No AB 075938 VINTAGE PHARMS
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 INC
PROPAFENONE HYDROCHLORIDE PROPAFENONE HYDROCHLORIDE 225MG TABLET;ORAL Prescription No AB 202445 AUROBINDO PHARMA LTD
PROPAFENONE HYDROCHLORIDE PROPAFENONE HYDROCHLORIDE 225MG TABLET;ORAL Prescription No AB 075998 SUN PHARM INDUSTRIES
PROPAFENONE HYDROCHLORIDE PROPAFENONE HYDROCHLORIDE 225MG TABLET;ORAL Prescription No AB 075938 VINTAGE PHARMS
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 INC
PROPAFENONE HYDROCHLORIDE PROPAFENONE HYDROCHLORIDE 300MG TABLET;ORAL Prescription No AB 202445 AUROBINDO PHARMA LTD
PROPAFENONE HYDROCHLORIDE PROPAFENONE HYDROCHLORIDE 300MG TABLET;ORAL Prescription No AB 075998 SUN PHARM INDUSTRIES
PROPAFENONE HYDROCHLORIDE PROPAFENONE HYDROCHLORIDE 300MG TABLET;ORAL Prescription No AB 075938 VINTAGE PHARMS

Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players.
Language Assistance Available: Español | 繁體中文 | Tiếng Việt | 한국어 | Tagalog | Русский | العربية | Kreyòl Ayisyen | Français | Polski | Português | Italiano | Deutsch | 日本語 | فارسی | English