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PENTOSTATIN

ANDA

PENTOSTATIN | A077841 | WEST-WARD PHARMACEUTICALS INTERNATIONAL LTD

1 strength0 unique patents0 unique exclusivities

Reference Listed Drug: NIPENT(TE code: AP)

API Supply Chain2 active DMFs

2 active API suppliers hold Drug Master Files for this ingredient. Limited supplier base — potential supply chain risk.

CHEMPACIFIC CORPPENTOSTATIN

DMF 182352005

MATRIX PHARMACORP PRIVATE LTDPENTOSTATIN

DMF 248622011

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

Approval Letters

1 letter from Drugs@FDA

Date	Submission	Document
Aug 14, 2007	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — 10MG/VIAL

0 patents0 exclusivities▴

INJECTABLE;INJECTION | Approved: Aug 7, 2007

No patent or exclusivity listings for this strength.