FDA Orange Book
Generic for Camptosar
Camptosar contains irinotecan. Orange Book status for every listed strength, the approved generic makers, and the listed patents and exclusivities.
Source: FDA Orange Book data file dated 2026-10-09. Publisher page
Yes. The generic name for Camptosar is irinotecan. 13 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AP.
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Camptosar products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| injectable, injection | 100MG/5ML (20MG/ML) | Marketed (Rx) | AP | 13 | AP |
| injectable, injection | 300MG/15ML (20MG/ML) | Marketed (Rx) | AP | 3 | AP |
| injectable, injection | 40MG/2ML (20MG/ML) | Marketed (Rx) | AP | 13 | AP |
NDA 020571, held by PFIZER INC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Approved generic irinotecan
| Company | ANDA | TE code | Approved | Strengths |
|---|---|---|---|---|
| ACTAVIS TOTOWA LLC | 078589 | AP (A-rated, therapeutically equivalent) | February 27, 2008 | 100MG/5ML (20MG/ML), 40MG/2ML (20MG/ML) |
| FRESENIUS KABI USA LLC | 077776 | AP (A-rated, therapeutically equivalent) | February 27, 2008 | 100MG/5ML (20MG/ML), 40MG/2ML (20MG/ML) |
| HOSPIRA INC | 077915 | AP (A-rated, therapeutically equivalent) | February 27, 2008 | 100MG/5ML (20MG/ML), 40MG/2ML (20MG/ML) |
| ACCORD HEALTHCARE INC | 079068 | AP (A-rated, therapeutically equivalent) | November 21, 2008 | 100MG/5ML (20MG/ML), 40MG/2ML (20MG/ML) |
| HIKMA PHARMACEUTICALS USA INC | 078753 | AP (A-rated, therapeutically equivalent) | December 24, 2008 | 100MG/5ML (20MG/ML), 40MG/2ML (20MG/ML) |
| EPIC PHARMA LLC | 090726 | AP (A-rated, therapeutically equivalent) | September 16, 2009 | 100MG/5ML (20MG/ML), 40MG/2ML (20MG/ML) |
| HIKMA FARMACEUTICA (PORTUGAL) SA | 091032 | AP (A-rated, therapeutically equivalent) | December 20, 2010 | 100MG/5ML (20MG/ML), 40MG/2ML (20MG/ML) |
| PHARMOBEDIENT CONSULTING LLC | 090393 | AP (A-rated, therapeutically equivalent) | May 13, 2011 | 100MG/5ML (20MG/ML), 40MG/2ML (20MG/ML) |
| QILU PHARMACEUTICAL HAINAN CO LTD | 203380 | AP (A-rated, therapeutically equivalent) | May 3, 2016 | 100MG/5ML (20MG/ML), 300MG/15ML (20MG/ML), 40MG/2ML (20MG/ML) |
| INTAS PHARMACEUTICALS USA | 203054 | AP (A-rated, therapeutically equivalent) | August 31, 2017 | 100MG/5ML (20MG/ML), 40MG/2ML (20MG/ML) |
| ADAPTIS PHARMA PRIVATE LTD | 208718 | AP (A-rated, therapeutically equivalent) | December 28, 2018 | 100MG/5ML (20MG/ML), 300MG/15ML (20MG/ML), 40MG/2ML (20MG/ML) |
| GLAND PHARMA LTD | 212993 | AP (A-rated, therapeutically equivalent) | November 18, 2019 | 100MG/5ML (20MG/ML), 40MG/2ML (20MG/ML) |
| EUGIA PHARMA SPECIALITIES LTD | 213278 | AP (A-rated, therapeutically equivalent) | November 2, 2020 | 100MG/5ML (20MG/ML), 300MG/15ML (20MG/ML), 40MG/2ML (20MG/ML) |
Camptosar NDC codes
Questions
Is there a generic for Camptosar?
Yes. The generic name for Camptosar is irinotecan. 13 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AP.
What is the generic name for Camptosar?
The active ingredient in Camptosar is irinotecan, per the FDA Orange Book.
What does a therapeutic equivalence code mean?
In the Orange Book, codes that start with A (such as AB) mean FDA considers the product therapeutically equivalent to the reference drug. Codes that start with B mean FDA does not, at this time, consider the product therapeutically equivalent.