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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 075203
Company: WATSON LABS
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
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-Patient Package Insert, Labeling-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.

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

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
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