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SUNITINIB MALATE

ANDA

SUNITINIB MALATE | A213803 | TEVA PHARMACEUTICALS USA

4 strengths0 unique patents0 unique exclusivities

Reference Listed Drug: SUTENT(TE code: AB)

API Supply Chain8 active DMFs2 inactive

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

TAPI NL BVSUNITINIB MALATE

DMF 234142009

RELIANCE LIFE SCIENCES PVT LTDSUNITINIB MALATE

DMF 290142015

SHILPA MEDICARE LTDSUNITINIB

DMF 296532021

MEDICHEM MANUFACTURING (MALTA) LTDSUNITINIB MALATE

DMF 305592016

SHILPA PHARMA LIFESCIENCES LTDSUNITINIB MALATE

DMF 330852018

MSN LABORATORIES PRIVATE LTDSUNITINIB MALATE

DMF 333082018

HETERO LABS LTDSUNITINIB MALATE

DMF 362012021

CDYMAX (INDIA) PHARMA PRIVATE LTDSUNITINIB MALATE

DMF 363922021

MYLAN LABORATORIES LTDInactiveSUNITINIB MALATE

DMF 245092010

SICHUAN XIELI PHARMACEUTICAL CO LTDInactiveSUNITINIB MALATE

DMF 264642012

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

Products (4)

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#001 — EQ 12.5MG BASE

0 patents0 exclusivities▴

CAPSULE;ORAL | Approved: Nov 30, 2021

No patent or exclusivity listings for this strength.

#002 — EQ 25MG BASE

0 patents0 exclusivities▾

CAPSULE;ORAL | Approved: Nov 30, 2021

#003 — EQ 37.5MG BASE

0 patents0 exclusivities▾

CAPSULE;ORAL | Approved: Nov 30, 2021

#004 — EQ 50MG BASE

0 patents0 exclusivities▾

CAPSULE;ORAL | Approved: Nov 30, 2021