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GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE

ANDA

DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN | A091070 | ACTAVIS LABORATORIES FL INC AN INDIRECT WHOLLY OWNED SUB OF TEVA PHARMACEUTICALS USA INC

2 strengths0 unique patents0 unique exclusivities

Approval Letters

1 letter from Drugs@FDA

Date	Submission	Document
Sep 4, 2015	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (2)

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#001 — 30MG;600MG

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TABLET, EXTENDED RELEASE;ORAL | Approved: Aug 31, 2015

No patent or exclusivity listings for this strength.

#002 — 60MG;1.2GM

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TABLET, EXTENDED RELEASE;ORAL | Approved: Aug 31, 2015