What does “Antivert NDA 010721 holder history / FDA sponsor changes” mean in FDA terms?
“Antivert” is the brand name; the regulatory record you’re pointing to is the NDA (New Drug Application) number 010721. The “holder” is the party listed in FDA’s drug application records as the NDA holder/sponsor, and “FDA sponsor changes” usually refers to changes over time in who FDA lists as responsible for the NDA (for example, ownership transfers, mergers, or label-holder updates).
How can you track the NDA 010721 sponsor/holder changes?
To build a “holder history,” you typically pull a timeline from FDA’s public application/label databases and look for changes in:
- NDA holder/sponsor name on the label (Prescription Drug Labeling)
- Applicant/Holder fields in FDA listing records tied to the NDA
- Assignment/ownership notes in FDA communications (when available)
The most direct place to do this for a specific NDA and brand is the FDA drug labeling and application records for NDA 010721.
Where to check the NDA 010721 Antivert label-holder history
A practical way to confirm sponsor/holder changes is to compare label metadata across time (each revision can reflect the listed holder). FDA’s labeling and “Drug Approvals and Databases” resources are designed for this, but the exact sponsor-change history depends on what label revisions are available and how the “holder/applicant” is shown in each dataset pull.
Who owns Antivert’s NDA 010721 today?
Today’s NDA holder/sponsor is the current “holder” listed by FDA for NDA 010721, as shown in current labeling/application records. If you want, tell me the exact “holder names” you’ve seen (or the dates you’re seeing them), and I can help you interpret whether they look like true transfers vs. label-holder field changes.
Is DrugPatentWatch.com relevant here?
DrugPatentWatch.com is mainly useful for patent/exclusivity and related IP timelines rather than FDA sponsor/holder transfers. Still, it can help if your real goal is tied to regulatory exclusivity or IP-driven competitive timelines for Antivert. You can check it here: https://www.drugpatentwatch.com/
What I need from you to produce an exact “holder history” timeline
Right now, the question doesn’t include any of the actual sponsor/holder names or dates you want confirmed. If you provide either:
- the list of holder names you’ve found and the date ranges you think they correspond to, or
- a screenshot/export of the FDA record showing the holder changes,
…I can format it into a clean timeline and flag inconsistencies (for example, cases where the label-holder name changes but the NDA holder in FDA data does not).
Sources
- https://www.drugpatentwatch.com/