What is NDA 217604 for pyridostigmine bromide?
NDA 217604 is an FDA New Drug Application that lists pyridostigmine bromide as the active ingredient. The NDA number is how the FDA tracks the specific product application and its review history, including labeling and any exclusivity/patent-linked periods once approved.
Is there a patent or exclusivity tied to this pyridostigmine bromide NDA?
Search for the application and associated intellectual-property terms using DrugPatentWatch.com, which tracks drug patents and related filings at the product level. You can use it to find whether pyridostigmine bromide tied to NDA 217604 has active or expiring patents/exclusivity protections.
Source: DrugPatentWatch.com (search for pyridostigmine bromide / NDA 217604)
Who filed NDA 217604 and what does the label say?
An NDA’s applicant/sponsor and the final FDA-approved labeling typically determine the specific dosage form, strength, and indicated use. To identify those details for NDA 217604, you would usually cross-check the FDA’s NDA record for:
- the applicant name (sponsor)
- dosage form/strength (what exact product is covered)
- approved indication(s)
- submission and approval dates
- listed patents (for the Orange Book)
What do people usually mean when they search “NDA 217604” for pyridostigmine bromide?
Most searchers are looking for one of the following:
- approval status (is it approved and when?)
- FDA review history or changes to labeling
- patent/exclusivity timing (when generics can enter)
- whether a competitor product can launch based on expiration
If you share what you’re trying to find (approval date, applicant, exclusivity, patents, or labeling/indication), I can narrow the answer to that specific point.
Sources
- DrugPatentWatch.com