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LAPATINIB DITOSYLATE

ANDA

LAPATINIB DITOSYLATE | A203007 | NATCO PHARMA LTD

1 strength0 unique patents0 unique exclusivities

Reference Listed Drug: TYKERB(TE code: AB)

API Supply Chain8 active DMFs1 inactive

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

FORMOSA LABORATORIES INCLAPATINIB DITOSYLATE

DMF 247882011

HETERO LABS LTDLAPATINIB DITOSYLATE MONOHYDRATE

DMF 276022013

ALP PHARM BEIJING CO LTDLAPATINIB DITOSYLATE

DMF 297122015

CAMBREX CHARLES CITY INCLAPATINIB DITOSYLATE MONOHYDRATE

DMF 298082015

SCINOPHARM TAIWAN LTDLAPATINIB DITOSYLATE

DMF 300432015

DELMAR CHEMICALS INCLAPATINIB DITOSYLATE

DMF 322662018

CHEMWERTH INCLAPATINIB DITOSYLATE MONOHYDRATE

DMF 348362021

MSN LABORATORIES PRIVATE LTDLAPATINIB DITOSYLATE MONOHYDRATE

DMF 352142021

GRANULES INDIA LTDInactiveLAPATINIB DITOSYLATE MONOHYDRATE

DMF 366022022

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

Approval Letters

1 letter from Drugs@FDA

Date	Submission	Document
Oct 30, 2020	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — EQ 250MG BASE

0 patents0 exclusivities▴

TABLET;ORAL | Approved: Sep 29, 2020

No patent or exclusivity listings for this strength.