Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 018830
Company: CNTY LINE PHARMS
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
TAMBOCOR FLECAINIDE ACETATE 100MG TABLET;ORAL Prescription AB Yes No
TAMBOCOR FLECAINIDE ACETATE 200MG TABLET;ORAL Discontinued None No No
TAMBOCOR FLECAINIDE ACETATE 150MG TABLET;ORAL Prescription AB Yes No
TAMBOCOR FLECAINIDE ACETATE 50MG TABLET;ORAL Prescription AB Yes 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
10/31/1985 ORIG-1 Approval Type 1 - New Molecular Entity STANDARD Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/018830Orig1s000rev.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
11/08/2017 SUPPL-24 Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/018830Orig1s024ltr.pdf
04/28/2000 SUPPL-20 Manufacturing (CMC)-Control

Label is not available on this site.

09/03/1999 SUPPL-19 Manufacturing (CMC)-Control

Label is not available on this site.

TAMBOCOR

TABLET;ORAL; 100MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
FLECAINIDE ACETATE FLECAINIDE ACETATE 100MG TABLET;ORAL Prescription No AB 075442 AMNEAL PHARM
FLECAINIDE ACETATE FLECAINIDE ACETATE 100MG TABLET;ORAL Prescription No AB 075882 ANI PHARMS INC
FLECAINIDE ACETATE FLECAINIDE ACETATE 100MG TABLET;ORAL Prescription No AB 202821 AUROBINDO PHARMA LTD
FLECAINIDE ACETATE FLECAINIDE ACETATE 100MG TABLET;ORAL Prescription No AB 076278 HIKMA
FLECAINIDE ACETATE FLECAINIDE ACETATE 100MG TABLET;ORAL Prescription No AB 076421 SUN PHARM INDS LTD
TAMBOCOR FLECAINIDE ACETATE 100MG TABLET;ORAL Prescription Yes AB 018830 CNTY LINE PHARMS

TABLET;ORAL; 150MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
FLECAINIDE ACETATE FLECAINIDE ACETATE 150MG TABLET;ORAL Prescription No AB 075442 AMNEAL PHARM
FLECAINIDE ACETATE FLECAINIDE ACETATE 150MG TABLET;ORAL Prescription No AB 075882 ANI PHARMS INC
FLECAINIDE ACETATE FLECAINIDE ACETATE 150MG TABLET;ORAL Prescription No AB 202821 AUROBINDO PHARMA LTD
FLECAINIDE ACETATE FLECAINIDE ACETATE 150MG TABLET;ORAL Prescription No AB 076278 HIKMA
FLECAINIDE ACETATE FLECAINIDE ACETATE 150MG TABLET;ORAL Prescription No AB 076421 SUN PHARM INDS LTD
TAMBOCOR FLECAINIDE ACETATE 150MG TABLET;ORAL Prescription Yes AB 018830 CNTY LINE PHARMS

TABLET;ORAL; 50MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
FLECAINIDE ACETATE FLECAINIDE ACETATE 50MG TABLET;ORAL Prescription No AB 075442 AMNEAL PHARM
FLECAINIDE ACETATE FLECAINIDE ACETATE 50MG TABLET;ORAL Prescription No AB 075882 ANI PHARMS INC
FLECAINIDE ACETATE FLECAINIDE ACETATE 50MG TABLET;ORAL Prescription No AB 202821 AUROBINDO PHARMA LTD
FLECAINIDE ACETATE FLECAINIDE ACETATE 50MG TABLET;ORAL Prescription No AB 076278 HIKMA
FLECAINIDE ACETATE FLECAINIDE ACETATE 50MG TABLET;ORAL Prescription No AB 076421 SUN PHARM INDS LTD
TAMBOCOR FLECAINIDE ACETATE 50MG TABLET;ORAL Prescription Yes AB 018830 CNTY LINE PHARMS

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