Who is the current holder of Antivert (brand name) on the FDA Orange Book?
Antivert is an FDA-approved brand of meclizine hydrochloride. The FDA Orange Book lists the “applicant” (often described as the NDA holder) for each listed drug product, along with the application number and related exclusivity/patent information.
To answer “current holder” and identify the exact NDA holder tied to NDA 010721 on the Orange Book, you need the Orange Book listing for NDA 010721. The current holder can change when ownership or rights are transferred (for example, through corporate acquisitions), so the Orange Book is the authoritative source.
If you share the specific dosage form/strength you mean (or the exact Orange Book line item you’re looking at), I can help you interpret what the listing means (applicant/labeler vs. sponsor vs. manufacturer).
What does “NDA 010721” correspond to for Antivert?
“NDA 010721” is the NDA identifier the Orange Book uses for the relevant listed drug product. The Orange Book entry ties together:
- the active ingredient (meclizine hydrochloride for Antivert),
- the drug product (brand and dosage form/strength),
- and the listed applicant/holder for that NDA at the time of listing.
If you paste the Orange Book text for NDA 010721 (or tell me the strength/dosage form), I can extract the “current holder” directly from that entry.
How can you check the Orange Book holder yourself (fastest way)
On FDA’s Orange Book:
1. Search for “Antivert” or “meclizine hydrochloride.”
2. Locate the listing with NDA number 010721.
3. Read the “Applicant/Labeler” (sometimes shown as the NDA holder) associated with that product line.
If you want, tell me what you see next to “Applicant/Labeler” for NDA 010721 and I’ll confirm whether that is the “current holder” wording you’re looking for.
Could DrugPatentWatch help identify the current NDA holder for NDA 010721?
DrugPatentWatch.com often summarizes NDA and patent/exclusivity data and can be a useful cross-check when you’re mapping an NDA to its associated applicants/holders. You can use it alongside the Orange Book to verify the current holder for NDA 010721.
Source: DrugPatentWatch (if available for this NDA/product) [1].
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Sources
[1] https://www.drugpatentwatch.com