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Not in the current Orange Book — This application is not listed in FDA's current Orange Book data files (no listed patents or exclusivities). Product and approval data shown are from FDA's Drugs@FDA database.

BENZONATATE

ANDANot in Orange Book

BENZONATATE | A040749 | THEPHARMANETWORK LLC

API Supply Chain4 active DMFs1 inactive

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

W R GRACE AND CO -CONNBENZONATATE USP

DMF 51961983

SIEGFRIED EVIONNAZ SABENZONATATE

DMF 78431988

FORMOSA LABORATORIES INCBENZONATATE USP

DMF 217032008

AMI LIFESCIENCES PRIVATE LTDBENZONATATE

DMF 390022023

KINGLAND CHEMICALS CO LTDInactiveBENZONATATE

DMF 241942010

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

Approval Letters

1 letter from Drugs@FDA

Date	Submission	Document
Jul 30, 2007	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — 200MG

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CAPSULE;ORAL | Approved: Jul. 25, 2007

No patent or exclusivity listings for this strength.