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DIGOXIN

ANDA

DIGOXIN | A076363 | SUN PHARMACEUTICAL INDUSTRIES INC

2 strengths0 unique patents0 unique exclusivities

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.

Products (2)

Sort:

#001 — 0.125MG

0 patents0 exclusivities▴

TABLET;ORAL | Approved: Jan 31, 2003

No patent or exclusivity listings for this strength.

#002 — 0.25MG

0 patents0 exclusivities▾

TABLET;ORAL | Approved: Jan 31, 2003

Change History (4)

Recent changes detected for this application.

MODIFIEDtype7/1/2026

Sun Pharma's Digoxin NDA 076363 changed from prescription (RX) status to discontinued (DISCN).

Old: RX

New: DISCN

MODIFIEDTE Code7/1/2026

SUN PHARM INDS INC's DIGOXIN (digoxin) product NDA 076363 had its therapeutic equivalence code changed from AB to a different designation.

Old: AB

MODIFIEDTE Code7/1/2026

Sun Pharmaceutical's Digoxin (digoxin) NDA 076363 therapeutic equivalence rating changed from AB to a different code.

Old: AB

MODIFIEDtype7/1/2026

Sun Pharma's digoxin NDA 076363 changed product type from prescription to discontinued.

Old: RX

New: DISCN