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NIZATIDINE

ANDA

NIZATIDINE | A075934 | MYLAN PHARMACEUTICALS INC.

2 strengths0 unique patents0 unique exclusivities

API Supply Chain2 active DMFs3 inactive

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

SOLARA ACTIVE PHARMA SCIENCES LTDNIZATIDINE USP

DMF 131921998

DR REDDYS LABORATORIES LTDNIZATIDINE USP

DMF 140361999

EURO CHEMI INCInactiveNIZATIDINE

DMF 141011999

WOCKHARDT LTDInactiveNIZATIDINE USP

DMF 147102000

OLON SPAInactiveNIZATIDINE

DMF 185452005

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

Approval Letters

1 letter from Drugs@FDA

Date	Submission	Document
Jun 24, 2004	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (2)

Sort:

#001 — 150MG

0 patents0 exclusivities▴

CAPSULE;ORAL | Approved: Jul 9, 2002

No patent or exclusivity listings for this strength.

#002 — 300MG

0 patents0 exclusivities▾

CAPSULE;ORAL | Approved: Jul 9, 2002