CAMPTOSAR — FDA application NDA020571
Listed sponsor: PFIZER INC · PFE 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
| Product | FDA-listed trade name | Active ingredient | Dosage form | Route | Strength | Marketing status | TE code | RLD |
|---|---|---|---|---|---|---|---|---|
| 001 | CAMPTOSAR | IRINOTECAN HYDROCHLORIDE | INJECTABLE | INJECTION | 40MG/2ML (20MG/ML) | Prescription | AP | Yes |
| 002 | CAMPTOSAR | IRINOTECAN HYDROCHLORIDE | INJECTABLE | INJECTION | 100MG/5ML (20MG/ML) | Prescription | AP | Yes |
| 003 | CAMPTOSAR | IRINOTECAN HYDROCHLORIDE | INJECTABLE | INJECTION | 300MG/15ML (20MG/ML) | Prescription | AP | Yes |
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
No Orange Book patent or exclusivity listings joined to this application.
Compound cross-links
- IRINOTECAN HYDROCHLORIDE · UNII 042LAQ1IIS · lmmol compound KLEAIHJJLUAXIQ-JDRGBKBRSA-N · CHEMBL3989514
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: Large-cap biopharma
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.