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:

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Harvard Business School
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Last Updated: October 20, 2019

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Generic Companies with Tentative Approvals for: Teva Parenteral

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Teva Parenteral Generic Filers with Tentative Approvals

The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.

Applicant Generic Name NDA Strength Dosage Form
Teva Parenteral gemcitabine 090644 2G INJECTABLE; INJECTION
Teva Parenteral pantoprazole sodium 022226 40MG INJECTABLE; INJECTION
Teva Parenteral zoledronic acid 078576 EQ 4MG BASE/VIAL INJECTABLE; IV (INFUSION)
Teva Parenteral zoledronic acid 078580 EQ 4MG BASE/VIAL INJECTABLE; IV (INFUSION)
Teva Parenteral sumatriptan succinate 078318 EQ 6MG BASE/0.5ML (EQ 12MG BASE/ML) INJECTABLE;SUBCUTANEOUS
>Applicant >Generic Name >NDA >Strength >Dosage Form

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Serving leading biopharmaceutical companies globally:

AstraZeneca
Medtronic
Colorcon
Moodys
Mallinckrodt
Baxter

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