FDA Orange Book
Generic for Paraplatin
Paraplatin contains carboplatin. 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 Paraplatin is carboplatin. 11 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AP. Generics match 4 of the 7 Paraplatin products the Orange Book lists.
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Paraplatin products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| injectable, injection | 150MG/VIAL | Discontinued | None | 0 | None |
| injectable, injection | 450MG/VIAL | Discontinued | None | 0 | None |
| injectable, injection | 50MG/VIAL | Discontinued | None | 0 | None |
| injectable, intravenous | 150MG/15ML (10MG/ML) | Discontinued | None | 10 | AP |
| injectable, intravenous | 450MG/45ML (10MG/ML) | Discontinued | None | 11 | AP |
| injectable, intravenous | 50MG/5ML (10MG/ML) | Discontinued | None | 10 | AP |
| injectable, intravenous | 600MG/60ML (10MG/ML) | Discontinued | None | 9 | AP |
NDA 019880, 020452, held by CORDEN PHARMA LATINA SPA. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Approved generic carboplatin
| Company | ANDA | TE code | Approved | Strengths |
|---|---|---|---|---|
| HOSPIRA INC | 076517 | AP (A-rated, therapeutically equivalent) | October 14, 2004 | 150MG/15ML (10MG/ML), 450MG/45ML (10MG/ML), 50MG/5ML (10MG/ML) |
| PHARMACHEMIE BV | 077269 | AP (A-rated, therapeutically equivalent) | October 14, 2004 | 150MG/15ML (10MG/ML), 450MG/45ML (10MG/ML), 50MG/5ML (10MG/ML), 600MG/60ML (10MG/ML) |
| HIKMA PHARMACEUTICALS USA INC | 077244 | AP (A-rated, therapeutically equivalent) | October 15, 2004 | 150MG/15ML (10MG/ML), 450MG/45ML (10MG/ML), 50MG/5ML (10MG/ML), 600MG/60ML (10MG/ML) |
| HOSPIRA INC | 077059 | AP (A-rated, therapeutically equivalent) | November 23, 2004 | 600MG/60ML (10MG/ML) |
| FRESENIUS KABI USA LLC | 077266 | AP (A-rated, therapeutically equivalent) | February 15, 2006 | 450MG/45ML (10MG/ML), 600MG/60ML (10MG/ML) |
| TEYRO LABS PRIVATE LTD | 077861 | AP (A-rated, therapeutically equivalent) | January 18, 2007 | 150MG/15ML (10MG/ML), 450MG/45ML (10MG/ML), 50MG/5ML (10MG/ML), 600MG/60ML (10MG/ML) |
| SANDOZ INC | 078280 | AP (A-rated, therapeutically equivalent) | May 8, 2008 | 150MG/15ML (10MG/ML), 450MG/45ML (10MG/ML), 50MG/5ML (10MG/ML) |
| SUN PHARMACEUTICAL INDUSTRIES LTD | 077926 | AP (A-rated, therapeutically equivalent) | September 19, 2008 | 150MG/15ML (10MG/ML), 450MG/45ML (10MG/ML), 50MG/5ML (10MG/ML) |
| EPIC PHARMA LLC | 090475 | AP (A-rated, therapeutically equivalent) | July 29, 2009 | 150MG/15ML (10MG/ML), 450MG/45ML (10MG/ML), 50MG/5ML (10MG/ML) |
| EPIC PHARMA LLC | 091268 | AP (A-rated, therapeutically equivalent) | July 28, 2010 | 600MG/60ML (10MG/ML) |
| EUGIA PHARMA SPECIALITIES LTD | 205487 | AP (A-rated, therapeutically equivalent) | March 28, 2016 | 150MG/15ML (10MG/ML), 450MG/45ML (10MG/ML), 50MG/5ML (10MG/ML), 600MG/60ML (10MG/ML) |
| ACCORD HEALTHCARE INC | 206775 | AP (A-rated, therapeutically equivalent) | February 9, 2017 | 150MG/15ML (10MG/ML), 450MG/45ML (10MG/ML), 50MG/5ML (10MG/ML), 600MG/60ML (10MG/ML) |
| GLAND PHARMA LTD | 207324 | AP (A-rated, therapeutically equivalent) | February 15, 2017 | 150MG/15ML (10MG/ML), 450MG/45ML (10MG/ML), 50MG/5ML (10MG/ML), 600MG/60ML (10MG/ML) |
Questions
Is there a generic for Paraplatin?
Yes. The generic name for Paraplatin is carboplatin. 11 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AP. Generics match 4 of the 7 Paraplatin products the Orange Book lists.
What is the generic name for Paraplatin?
The active ingredient in Paraplatin is carboplatin, 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.