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FLUVOXAMINE MALEATE

ANDA

FLUVOXAMINE MALEATE | A091476 | PH HEALTH LTD

2 strengths0 unique patents0 unique exclusivities

Drug Pricing (NADAC)

National Average Drug Acquisition Cost — Week of 2026-07-15 | 2 NDCs

Highest NADAC/Unit

$4.96

per ea

Lowest NADAC/Unit

$4.87

per ea

Brand NDCs

Generic NDCs

NDC Description	NADAC/Unit	Unit	Type	Generic NADAC	Effective
10370017611FLUVOXAMINE ER 150 MG CAPSULE	$4.96	EA	Generic	—	2026-06-17
10370017511FLUVOXAMINE ER 100 MG CAPSULE	$4.87	EA	Generic	—	2026-06-17

Source: NADAC (data.medicaid.gov). Prices reflect national average acquisition costs for retail community pharmacies.

API Supply Chain12 active DMFs3 inactive

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

TAPI NL BVFLUVOXAMINE MALEATE

DMF 139131998

MEDICHEM SAFLUVOXAMINE MALEATE

DMF 145111999

APOTEX PHARMACHEM INDIA PVT LTDFLUVOXAMINE MALEATE USP

DMF 145291999

SUN PHARMACEUTICAL INDUSTRIES LTDFLUVOXAMINE MALEATE USP

DMF 161742002

VERANOVA LPFLUVOXAMINE MALEATE (SVB)

DMF 205692007

LONZA AGFLUVOXAMINE MALEATE (SV-006)

DMF 252012011

COHANCE LIFESCIENCES LTDFLUVOXAMINE MALEATE USP

DMF 295822015

DASAMI LAB PRIVATE LTDFLUVOXAMINE MALEATE USP

DMF 363032021

JEWIM PHARMACEUTICAL (SHANDONG) CO LTDFLUVOXAMINE MALEATE

DMF 390192023

ALIVUS LIFE SCIENCES LTDFLUVOXAMINE MALEATE USP

DMF 416102025

SHANDONG RISEN-SUN PHARMACEUTICAL CO LTDFLUVOXAMINE MALEATE

DMF 432652025

AMI LIFESCIENCES PRIVATE LTDFLUVOXAMINE MALEATE

DMF 435472026

VIS FARMACEUTICI INSTITUTO SCIENTIFICO VINEZIE SPAInactiveFLUVOXAMINE MALEATE

DMF 123531997

DIOSYNTH BVInactiveFLUVOXAMINE MALEATE

DMF 138921998

ALKERMES INCInactiveFLUVOXAMINE MALEATE CR CAPSULES

DMF 139571999

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

Approval Letters

1 letter from Drugs@FDA

Date	Submission	Document
Mar 15, 2013	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (2)

Sort:

#001 — 100MG

0 patents0 exclusivities▴

CAPSULE, EXTENDED RELEASE;ORAL | Approved: Mar 13, 2013

No patent or exclusivity listings for this strength.

#002 — 150MG

0 patents0 exclusivities▾

CAPSULE, EXTENDED RELEASE;ORAL | Approved: Mar 13, 2013