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FLECAINIDE ACETATE

ANDA

FLECAINIDE ACETATE | A076030 | ANI PHARMACEUTICALS INC

3 strengths0 unique patents0 unique exclusivities

API Supply Chain10 active DMFs2 inactive

8 active API suppliers hold Drug Master Files for this ingredient.

MAPRIMED SAFLECAINIDE ACETATE PROCESS I (CODE 50064)

DMF 106881994

AMSA ANONIMA MATERIE SINTETICHE AND AFFINI SPAFLECAINIDE ACETATE

DMF 147492000

UNIMARK REMEDIES LTDFLECAINIDE ACETATE USP

DMF 192722006

UNIMARK REMEDIES LTDFLECAINIDE ACETATE USP (PROCESS B)

DMF 231922009

EMCURE PHARMACEUTICALS LTDFLECAINIDE ACETATE USP

DMF 278592014

MAPRIMED SAFLECAINIDE ACETATE PROCESS III (CODE 50970)

DMF 281582014

APITORIA PHARMA PRIVATE LTDFLECAINIDE ACETATE USP

DMF 317572017

SOLARA ACTIVE PHARMA SCIENCES LTDFLECAINIDE ACETATE USP

DMF 336662019

MSN LIFE SCIENCES PRIVATE LTDFLECAINIDE ACETATE USP

DMF 357602021

OMSAV PHARMA RESEARCH PRIVATE LTDFLECAINIDE ACETATE USP

DMF 372122022

POLYCARBON INDUSTRIES INC DBA PCI SYNTHESISInactiveFLECAINIDE ACETATE USP

DMF 152442001

MAPRIMED SAInactiveFLECAINIDE ACETATE PROCESS II (CODE 50856)

DMF 243092010

Source: FDA Drug Master Files (fda.gov). Type II API DMFs matched by ingredient.

Approval Letters

1 letter from Drugs@FDA

Date	Submission	Document
Apr 16, 2003	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (3)

Sort:

#001 — 50MG

0 patents0 exclusivities▴

TABLET;ORAL | Approved: Oct 28, 2002

No patent or exclusivity listings for this strength.

#002 — 100MG

0 patents0 exclusivities▾

TABLET;ORAL | Approved: Oct 28, 2002

#003 — 150MG

0 patents0 exclusivities▾

TABLET;ORAL | Approved: Oct 28, 2002