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Omsav Pharma Flecainide Acetate ANDA 218093 Approved

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Summary

The FDA approved ANDA 218093 for Flecainide Acetate tablets (50mg, 100mg, 150mg) held by Omsav Pharma on April 22, 2026. The drug received TE Code AB designation as a generic antiarrhythmic medication. Flecainide Acetate is now approved for prescription marketing in three dosage strengths.

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What changed

The FDA granted approval to ANDA 218093 for Flecainide Acetate tablets at three strengths (50mg, 100mg, 150mg). Omsav Pharma's product was designated as a generic antiarrhythmic with TE Code AB, indicating therapeutic equivalence to the reference listed drug. The approval was issued under STANDARD review classification.

Pharmaceutical manufacturers and healthcare providers may now consider Omsav Pharma as an additional approved supplier for Flecainide Acetate tablets. The addition of another approved ANDA increases market competition for this antiarrhythmic agent.

Archived snapshot

Apr 24, 2026

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Abbreviated New Drug Application (ANDA): 218093
Company: OMSAV PHARMA
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Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
FLECAINIDE ACETATE FLECAINIDE ACETATE 50MG TABLET;ORAL Prescription AB No No
FLECAINIDE ACETATE FLECAINIDE ACETATE 100MG TABLET;ORAL Prescription AB No No
FLECAINIDE ACETATE FLECAINIDE ACETATE 150MG 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
04/22/2026 ORIG-1 Approval STANDARD Label is not available on this site.

FLECAINIDE ACETATE

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
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 218093 OMSAV PHARMA
FLECAINIDE ACETATE FLECAINIDE ACETATE 50MG TABLET;ORAL Prescription No AB 210683 REGCON HOLDINGS
FLECAINIDE ACETATE FLECAINIDE ACETATE 50MG TABLET;ORAL Prescription No AB 076421 SUN PHARM INDS LTD
FLECAINIDE ACETATE FLECAINIDE ACETATE 50MG TABLET;ORAL Prescription No AB 215599 YICHANG HUMANWELL

TABLET;ORAL; 100MG
TE Code = AB

| 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 |
| 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 | 218093 | OMSAV PHARMA |
| FLECAINIDE ACETATE | FLECAINIDE ACETATE | 100MG | TABLET;ORAL | Prescription | No | AB | 210683 | REGCON HOLDINGS |
| FLECAINIDE ACETATE | FLECAINIDE ACETATE | 100MG | TABLET;ORAL | Prescription | No | AB | 076421 | SUN PHARM INDS LTD |
| FLECAINIDE ACETATE | FLECAINIDE ACETATE | 100MG | TABLET;ORAL | Prescription | No | AB | 215599 | YICHANG HUMANWELL |
TABLET;ORAL; 150MG
TE Code = AB

| 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 |
| 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 | 218093 | OMSAV PHARMA |
| FLECAINIDE ACETATE | FLECAINIDE ACETATE | 150MG | TABLET;ORAL | Prescription | No | AB | 210683 | REGCON HOLDINGS |
| FLECAINIDE ACETATE | FLECAINIDE ACETATE | 150MG | TABLET;ORAL | Prescription | No | AB | 076421 | SUN PHARM INDS LTD |
| FLECAINIDE ACETATE | FLECAINIDE ACETATE | 150MG | TABLET;ORAL | Prescription | No | AB | 215599 | YICHANG HUMANWELL |

Parties

OMSAV PHARMA

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Classification

Agency
FDA
Published
April 22nd, 2026
Instrument
Rule
Branch
Executive
Legal weight
Binding
Stage
Final
Change scope
Minor

Who this affects

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Pharmaceutical companies Healthcare providers Drug manufacturers
Industry sector
3254 Pharmaceutical Manufacturing
Activity scope
Generic drug approval Pharmaceutical marketing Drug approval
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United States US

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Pharmaceuticals
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