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TOPOTECAN HYDROCHLORIDE

ANDA

TOPOTECAN HYDROCHLORIDE | A091089 | FRESENIUS KABI USA LLC

1 strength0 unique patents0 unique exclusivities

Reference Listed Drug: HYCAMTIN(TE code: AP)

API Supply Chain3 active DMFs5 inactive

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

SCINOPHARM TAIWAN LTDTOPOTECAN HYDROCHLORIDE DRUG SUBSTANCE

DMF 208102007

EMCURE PHARMACEUTICALS LTDTOPOTECAN HYDROCHLORIDE

DMF 234432010

NOVARTIS PHARMACEUTICALS CORPTOPOTECAN HYDROCHLORIDE

DMF 244582011

DR REDDYS LABORATORIES LTDInactiveTOPOTECAN HYDROCHLORIDE

DMF 198342006

SAI PHYTOCEUTICALS PVT LTDInactiveTOPOTECAN HYDROCHLORIDE

DMF 207232007

CIPLA LTDInactiveTOPOTECAN HYDROCHLORIDE

DMF 216212008

FRESENIUS KABI ONCOLOGY LTDInactiveTOPOTECAN HYDROCHLORIDE

DMF 223032009

SYNBIAS PHARMA LTDInactiveTOPOTECAN HYDROCHLORIDE

DMF 236822010

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 3, 2010	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — EQ 4MG BASE/VIAL

0 patents0 exclusivities▴

INJECTABLE;INJECTION | Approved: Nov 29, 2010

No patent or exclusivity listings for this strength.