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MODAFINIL

ANDA

MODAFINIL | A078963 | ORBION PHARMACEUTICALS PRIVATE LTD

2 strengths0 unique patents0 unique exclusivities

Reference Listed Drug: PROVIGIL(TE code: AB)

API Supply Chain10 active DMFs4 inactive

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

CEPHALON INCMODAFINIL DRUG SUBSTANCE

DMF 119701996

WAVELENGTH ENTERPRISES LTDMODAFINIL

DMF 161402002

DIPHARMA FRANCIS SRLMODAFINIL USP

DMF 162502002

MATRIX PHARMACORP PRIVATE LTDMODAFINIL USP

DMF 163062002

TAPI NL BVMODAFINIL

DMF 163102002

ALEMBIC PHARMACEUTICALS LTDMODAFINIL USP

DMF 164772003

ORBION PHARMACEUTICALS PRIVATE LTDMODAFINIL

DMF 196452006

APITORIA PHARMA PRIVATE LTDMODAFINIL USP (NON-STERILE DRUG SUBSTANCE)

DMF 238982010

CHROMO LABORATORIES INDIA PRIVATE LTDMODAFINIL USP

DMF 369752022

SYMED LABS LTDMODAFINIL USP

DMF 385332023

UNION QUIMICO FARMACEUTICA SA (UQUIFA SA)InactiveMODAFINIL

DMF 175452004

HAS HEALTHCARE ADVANCED SYNTHESIS SAInactiveMODAFINIL

DMF 178152004

FLAMMA SPAInactiveMODAFINIL

DMF 180622005

SUN PHARMACEUTICAL INDUSTRIES LTDInactiveMODAFINIL

DMF 184112005

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

Products (2)

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#001 — 100MG

0 patents0 exclusivities▴

TABLET;ORAL | Approved: Sep 26, 2012

No patent or exclusivity listings for this strength.

#002 — 200MG

0 patents0 exclusivities▾

TABLET;ORAL | Approved: Sep 26, 2012