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In the past 5 years, Pharmadax had submitted or received approval from FDA for several generic products which the reference drugs were blockbuster drugs.

Glyburide

1.25mg / 2.5mg / 5mg

Glyburide tablet is indicated as an adjunct to diet and exercise to improveglycemic control in adults with type 2 diabetes mellitus.

Pharmadax received FDA approval in 2016.

Quetiapine Fumarate ER

50mg/ 150mg / 200mg / 300mg / 400mg

Quetiapine Fumarate ER tablet is the generic version of AstraZeneca’s Seroquel XR® tablet, which is indicated for the treatment ofSchizophrenia. Seroquel XR® had sales of approximately $1.03 billion in 2015.

Pharmadax received FDA approval in 2017.

Metoprolol Succinate ER

25mg / 50mg / 100mg / 200mg

Metoprolol Succinate ER tablet is the generic version of Toprol-XL® Tablet which is indicated for the treatment of high blood pressure. The brand company is AstraZeneca. Toprol-XL® had sales of approximately $1.21 billion in 2010.

Pharmadax filed ANDA submission in 2011.

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