grepcent public filings, reorganized for comparison

TOBI PODHALER — FDA application NDA201688

Application NDA201688 · type NDA · FDA status: approved · original approval 2013-03-22

Listed sponsor: VIATRIS · VTRS company profile · exact_unique

Sponsor as listed in Drugs@FDA at retrieval (2026-08-07); FDA sponsor listings can lag ownership transfers.

FDA application facts

ProductFDA-listed trade nameActive ingredientDosage formRouteStrengthMarketing statusTE codeRLD
001TOBI PODHALERTOBRAMYCINPOWDERINHALATION28MGPrescriptionnot listedYes

Product, form, strength, reference-drug and marketing-status fields: Drugs@FDA data files; TE and RLD fields: Orange Book data files. Retrieved 2026-08-07.

Orange Book patent and exclusivity listings

ListingProductDescriptive dateFlags/code
Patent 8869794001listed patent expiry date: 2028-09-12drug product, U-909
Patent 10207066001listed patent expiry date: 2030-11-04drug product, U-909
NDA201688 FDA listing dates. Source: Drugs@FDA and FDA Orange Book.NDA201688 FDA listing dates. Source: Drugs@FDA and FDA Orange Book.NDA201688 FDA listing datesDescriptive regulatory dates only; no relationship to revenue or future sales is stated or implied.Source: Drugs@FDA and FDA Orange Book.Listed dateDated listing marker0.001.002.002013-03-221.002028-09-121.002030-11-041.00

Patent and exclusivity dates are regulatory listings from the FDA Orange Book; no relationship to revenue or future sales is stated or implied.

Compound cross-links

Ingredient–compound links use FDA openFDA/GSRS identifiers and an exact lmmol InChIKey join. Ingredient names cannot create a link.

Related pages

Sponsor company · FDA-approved application index

Peer clusters: No published peer-cluster link for this sponsor.

Sources: Drugs@FDA · Orange Book · openFDA application record. FDA data retrieved 2026-08-07.

Regulatory listing data as published by FDA; not medical or investment advice.