Make Better Decisions - Finding and Evaluating Generic and Branded Drug Market Entry Opportunities

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Finding and Evaluating Generic and Branded Drug Market Entry Opportunities

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Serving leading biopharmaceutical companies globally:

Merck
Harvard Business School
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Dow
AstraZeneca
Medtronic

Last Updated: December 7, 2019

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Suppliers and packages for tradename: OSMOLEX ER

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OSMOLEX ER

Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.

Applicant Tradename Generic Name Dosage NDA NDA/ANDA Supplier Package Code Package
Osmotica Pharm OSMOLEX ER amantadine hydrochloride TABLET, EXTENDED RELEASE;ORAL 209410 NDA Vertical Pharmaceuticals, LLC 68025-074-62 1 KIT in 1 CARTON (68025-074-62) * 30 TABLET, EXTENDED RELEASE in 1 BOTTLE (68025-076-30) * 30 TABLET, EXTENDED RELEASE in 1 BOTTLE (68025-075-30)
Osmotica Pharm OSMOLEX ER amantadine hydrochloride TABLET, EXTENDED RELEASE;ORAL 209410 NDA Vertical Pharmaceuticals, LLC 68025-075-30 30 TABLET, EXTENDED RELEASE in 1 BOTTLE (68025-075-30)
Osmotica Pharm OSMOLEX ER amantadine hydrochloride TABLET, EXTENDED RELEASE;ORAL 209410 NDA Vertical Pharmaceuticals, LLC 68025-075-90 90 TABLET, EXTENDED RELEASE in 1 BOTTLE (68025-075-90)
Osmotica Pharm OSMOLEX ER amantadine hydrochloride TABLET, EXTENDED RELEASE;ORAL 209410 NDA Vertical Pharmaceuticals, LLC 68025-076-30 30 TABLET, EXTENDED RELEASE in 1 BOTTLE (68025-076-30)
Osmotica Pharm OSMOLEX ER amantadine hydrochloride TABLET, EXTENDED RELEASE;ORAL 209410 NDA Vertical Pharmaceuticals, LLC 68025-076-90 90 TABLET, EXTENDED RELEASE in 1 BOTTLE (68025-076-90)
Osmotica Pharm OSMOLEX ER amantadine hydrochloride TABLET, EXTENDED RELEASE;ORAL 209410 NDA Vertical Pharmaceuticals, LLC 68025-077-30 30 TABLET, EXTENDED RELEASE in 1 BOTTLE (68025-077-30)
Osmotica Pharm OSMOLEX ER amantadine hydrochloride TABLET, EXTENDED RELEASE;ORAL 209410 NDA Vertical Pharmaceuticals, LLC 68025-077-90 90 TABLET, EXTENDED RELEASE in 1 BOTTLE (68025-077-90)
>Applicant >Tradename >Generic Name >Dosage >NDA >NDA/ANDA >Supplier >Package Code >Package

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Serving leading biopharmaceutical companies globally:

Merck
AstraZeneca
Baxter
Colorcon
Medtronic
Express Scripts

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