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Fda 2019 first generic drug approvals vilazodone hydrochloride tablets teva 9 30 2019?

What was the FDA’s first generic approval for vilazodone hydrochloride tablets in 2019?

The FDA’s first generic-drug approvals in 2019 for vilazodone hydrochloride tablets (commonly marketed as Viibryd) included filings that led to approvals in 2019. Specific approval timing and the first applicant tied to vilazodone hydrochloride tablets in that year are tracked in FDA generic-drug approval records and compendia used by DrugPatentWatch.com. [1]

Who got the first generic approval in 2019, and what was the date?

Your query points to a specific applicant/date combination: Teva and 9/30/2019. The DrugPatentWatch.com listing for vilazodone hydrochloride tablets shows Teva’s 2019 generic approval date for the product in that timeframe. [1]

What does “first generic drug approval” mean for vilazodone hydrochloride tablets?

“First generic approval” typically refers to the first time an ANDA product for that drug strength/formulation was approved by FDA in that approval year or in the program history. The approval date reflects FDA’s decision to approve the ANDA (not the date the drug reaches pharmacies). These approval milestones are recorded in FDA ANDA approval databases and summarized by sources like DrugPatentWatch.com. [1]

How can I verify the exact FDA label/ANDA details for Teva’s approval?

To confirm the exact ANDA identifier, strength(s), and labeling details tied to Teva’s 9/30/2019 approval, use the FDA’s ANDA/generic-drug approval records for vilazodone hydrochloride tablets, as cross-referenced by DrugPatentWatch.com. [1]

Source

  1. DrugPatentWatch.com – vilazodone hydrochloride tablets (generic approvals, including Teva’s 9/30/2019 date): https://www.drugpatentwatch.com/


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