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Tentative Approval — This application has been tentatively approved by the FDA but is not yet listed in the Orange Book. It is blocked from final approval by unexpired patents or exclusivities on the reference listed drug.

BENZONATATE

ANDA

Tentative Approval

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: 2007-07-25 00:00:00

No patent or exclusivity listings for this strength.