Viewing data from:

DALFAMPRIDINE

ANDA

DALFAMPRIDINE | A210158 | MICRO LABS LTD

1 strength0 unique patents0 unique exclusivities

Reference Listed Drug: AMPYRA(TE code: AB)

Drug Pricing (NADAC)

National Average Drug Acquisition Cost — Week of 2026-07-15 | 1 NDC

Highest NADAC/Unit

$0.3928

per ea

Lowest NADAC/Unit

$0.3928

per ea

Brand NDCs

Generic NDCs

NDC Description	NADAC/Unit	Unit	Type	Generic NADAC	Effective
42571027560DALFAMPRIDINE ER 10 MG TABLET	$0.3928	EA	Generic	—	2026-06-17

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

API Supply Chain10 active DMFs1 inactive

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

CU CHEMIE UETIKON GMBHDALFAMPRIDINE

DMF 178602004

JUBILANT PHARMOVA LTDDALFAMPRIDINE USP

DMF 247182011

INDUSTRIALE CHIMICA SRLDALFAMPRIDINE

DMF 276232013

ALKEM LABORATORIES LTDDALFAMPRIDINE USP

DMF 276372013

PROCOS SPADALFAMPRIDINE

DMF 276472013

SUN PHARMACEUTICAL INDUSTRIES LTDDALFAMPRIDINE USP

DMF 276622013

INTAS PHARMACEUTICALS LTDDALFAMPRIDINE

DMF 278192013

APITORIA PHARMA PRIVATE LTDDALFAMPRIDINE

DMF 278432014

MICRO LABS LTDDALFAMPRIDINE USP

DMF 331462018

SHANDONG NEW TIME PHARMACEUTICAL CO LTDDALFAMPRIDINE

DMF 420752025

ENALTEC LABS PRIVATE LTDInactiveDALFAMPRIDINE

DMF 256952012

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

Approval Letters

2 letters from Drugs@FDA

Date	Submission	Document
Feb 21, 2019	ORIG -1	View Letter (PDF)
Aug 20, 2018	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — 10MG

0 patents0 exclusivities▴

TABLET, EXTENDED RELEASE;ORAL | Approved: Mar 11, 2019

No patent or exclusivity listings for this strength.