Viewing data from:

DAPSONE

ANDA

DAPSONE | A212657 | CHARTWELL RX SCIENCES LLC

1 strength0 unique patents0 unique exclusivities

API Supply Chain12 active DMFs2 inactive

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

LUNDBECK PHARMACEUTICALS ITALY SPADAPSONE

DMF 150652000

ATUL LTDDAPSONE USP

DMF 177812004

NOVITIUM PHARMA LLCDAPSONE USP

DMF 276782013

SAI LIFE SCIENCES LTDDAPSONE USP

DMF 277012013

TARO PHARMACEUTICAL INDUSTRIES LTDDAPSONE USP

DMF 299992016

DIPHARMA FRANCIS SRLDAPSONE

DMF 315212017

MACLEODS PHARMACEUTICALS LTDDAPSONE

DMF 332282019

EXTROVIS AGDAPSONE

DMF 336302019

MACLEODS PHARMACEUTICALS LTDDAPSONE USP

DMF 352442021

COHANCE LIFESCIENCES LTDDAPSONE USP

DMF 353422020

MEDILUX LABORATORIES PVT LTDDAPSONE USP

DMF 383782023

CHONGQING HUAPONT PHARMACEUTICAL CO LTDDAPSONE

DMF 384832023

JACOBUS PHARMACEUTICAL COInactiveDAPSONE (FINAL DOSAGE FORMS)

DMF 74131988

MEDILUX LABORATORIES PVT LTDInactiveDAPSONE USP

DMF 357862022

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

Products (1)

#001 — 7.5%

0 patents0 exclusivities▴

GEL;TOPICAL | Approved: Nov 1, 2023

No patent or exclusivity listings for this strength.

Change History (2)

Recent changes detected for this application.

MODIFIEDApplicant7/1/2026

Applicant for Dapsone (dapsone) NDA 212657 changed from Padagis Israel to Chartwell Rx.

Old: PADAGIS ISRAEL

New: CHARTWELL RX

MODIFIEDApplicant Full Name7/1/2026

CHARTWELL RX SCIENCES LLC became the listed applicant for dapsone (NDA 212657) following a change in ownership or control from PADAGIS ISRAEL PHARMACEUTICALS LTD.

Old: PADAGIS ISRAEL PHARMACEUTICALS LTD

New: CHARTWELL RX SCIENCES LLC