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DIGOXIN

ANDA

DIGOXIN | A076268 | JEROME STEVENS PHARMACEUTICALS INC

2 strengths0 unique patents0 unique exclusivities

Reference Listed Drug: LANOXIN(TE code: AB)

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

1 letter from Drugs@FDA

Date	Submission	Document
Dec 24, 2003	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (2)

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#001 — 0.125MG

0 patents0 exclusivities▴

TABLET;ORAL | Approved: Jul 26, 2002

No patent or exclusivity listings for this strength.

#002 — 0.25MG

0 patents0 exclusivities▾

TABLET;ORAL | Approved: Jul 26, 2002