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DIGOXIN

NDA

DIGOXIN | N021648 | HIKMA PHARMACEUTICALS USA INC

1 strength0 unique patents0 unique exclusivities

PTAB Proceedings

No IPR/PGR/CBM challenges found at the Patent Trial and Appeal Board

Patent Reexaminations

No ex parte or inter partes reexamination proceedings found at USPTO

Hatch-Waxman Litigation

No ANDA patent litigation cases (NOS 835) matched from PACER

Citizen Petitions

No FDA citizen petitions matched from Regulations.gov

Clinical Trials

No clinical trials found on ClinicalTrials.gov for this drug

API Supply Chain3 active DMFs8 inactive

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

C-SQUARED PHARMA LTDDIGOXIN

DMF 244182010

ALKALOIDS CORPDIGOXIN MICRO USP

DMF 286282014

ALCHEM INTERNATIONAL PRIVATE LTDDIGOXIN USP

DMF 307242016

RP SCHERER CORPInactiveDIGOXIN CAPS

DMF 22531974

ROCHE DIAGNOSTICS GMBHInactiveDIGOXIN PRODUCTS

DMF 22771974

BOEHRINGER INGELHEIM PHARMA GMBH AND CO KGInactiveDIGOXIN

DMF 69261987

PROCTER AND GAMBLE PHARMACEUTICALS INC SUB PROCTER AND GAMBLE COInactiveDIGOXIN DRUG SUBSTANCE

DMF 100671993

BOEHRINGER INGELHEIM PHARMA GMBH AND CO KGInactiveDIGOXIN 20 MICROMETER

DMF 215592008

VITAL LABORATORIES PVT LTDInactiveDIGOXIN

DMF 241352010

ALCHEM INTERNATIONAL LTDInactiveDIGOXIN USP

DMF 276052013

C-SQUARED PHARMA SARLInactiveDIGOXIN (MICRON)

DMF 330352019

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

Approval Letters

9 letters from Drugs@FDA

Date	Submission	Document
Apr 21, 2025	SUPPL -13	View Letter (PDF)
Apr 26, 2024	SUPPL -15	View Letter (PDF)
Aug 24, 2018	SUPPL -11	View Letter (PDF)
Dec 15, 2016	SUPPL -9	View Letter (PDF)
Jul 29, 2015	SUPPL -8	View Letter (PDF)
Oct 2, 2012	SUPPL -6	View Letter (PDF)
Nov 22, 2011	SUPPL -5	View Letter (PDF)
Oct 3, 2011	SUPPL -4	View Letter (PDF)
Aug 31, 2004	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — 0.05MG/ML

RLDAA

0 patents0 exclusivities▴

ELIXIR;ORAL | Approved: Aug 26, 2004

No patent or exclusivity listings for this strength.