FDA Orange Book
Generic for Kytril
Kytril contains granisetron. 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 Kytril is granisetron. 13 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB, AP. Generics match 5 of the 7 Kytril products the Orange Book lists.
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Kytril products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| injectable, injection | EQ 0.1MG BASE/ML (EQ 0.1MG BASE/ML) | Discontinued | None | 7 | AP |
| injectable, injection | EQ 1MG BASE/ML (EQ 1MG BASE/ML) | Discontinued | None | 9 | AP |
| injectable, injection | EQ 3MG BASE/ML | Discontinued | None | 0 | None |
| injectable, injection | EQ 4MG BASE/4ML (EQ 1MG BASE/ML) | Discontinued | None | 11 | AP |
| solution, oral | EQ 2MG BASE/10ML | Discontinued | None | 1 | None |
| tablet, oral | EQ 1MG BASE | Discontinued | None | 4 | AB |
| tablet, oral | EQ 2MG BASE | Discontinued | None | 0 | None |
NDA 020239, 021238, 020305, held by HOFFMANN LA ROCHE INC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Approved generic granisetron
| Company | ANDA | TE code | Approved | Strengths |
|---|---|---|---|---|
| AMNEAL EU LTD | 078262 | AP (A-rated, therapeutically equivalent) | December 31, 2007 | EQ 0.1MG BASE/ML (EQ 0.1MG BASE/ML) |
| DR REDDYS LABORATORIES LTD | 078392 | AP (A-rated, therapeutically equivalent) | December 31, 2007 | EQ 0.1MG BASE/ML (EQ 0.1MG BASE/ML) |
| FRESENIUS KABI USA LLC | 078522 | AP (A-rated, therapeutically equivalent) | December 31, 2007 | EQ 0.1MG BASE/ML (EQ 0.1MG BASE/ML) |
| HIKMA PHARMACEUTICALS USA INC | 077177 | AP (A-rated, therapeutically equivalent) | December 31, 2007 | EQ 4MG BASE/4ML (EQ 1MG BASE/ML) |
| ORBION PHARMACEUTICALS PRIVATE LTD | 078678 | AB (A-rated, therapeutically equivalent) | February 13, 2008 | EQ 1MG BASE |
| CHARTWELL MOLECULAR HOLDINGS LLC | 078037 | AB (A-rated, therapeutically equivalent) | February 27, 2008 | EQ 1MG BASE |
| HIKMA PHARMACEUTICALS USA INC | 077913 | AP (A-rated, therapeutically equivalent) | June 26, 2008 | EQ 0.1MG BASE/ML (EQ 0.1MG BASE/ML) |
| BIONPHARMA INC | 078863 | AP (A-rated, therapeutically equivalent) | June 30, 2008 | EQ 0.1MG BASE/ML (EQ 0.1MG BASE/ML), EQ 1MG BASE/ML (EQ 1MG BASE/ML) |
| AMNEAL EU LTD | 078258 | AP (A-rated, therapeutically equivalent) | June 30, 2008 | EQ 1MG BASE/ML (EQ 1MG BASE/ML), EQ 4MG BASE/4ML (EQ 1MG BASE/ML) |
| HIKMA PHARMACEUTICALS USA INC | 077187 | AP (A-rated, therapeutically equivalent) | June 30, 2008 | EQ 1MG BASE/ML (EQ 1MG BASE/ML) |
| SANDOZ INC | 078835 | AP (A-rated, therapeutically equivalent) | June 30, 2008 | EQ 1MG BASE/ML (EQ 1MG BASE/ML), EQ 4MG BASE/4ML (EQ 1MG BASE/ML) |
| FRESENIUS KABI USA LLC | 078096 | AP (A-rated, therapeutically equivalent) | June 30, 2008 | EQ 1MG BASE/ML (EQ 1MG BASE/ML) |
| BIONPHARMA INC | 078880 | AP (A-rated, therapeutically equivalent) | June 30, 2008 | EQ 4MG BASE/4ML (EQ 1MG BASE/ML) |
| DR REDDYS LABORATORIES LTD | 077297 | AP (A-rated, therapeutically equivalent) | June 30, 2008 | EQ 4MG BASE/4ML (EQ 1MG BASE/ML) |
| FRESENIUS KABI USA LLC | 078090 | AP (A-rated, therapeutically equivalent) | June 30, 2008 | EQ 4MG BASE/4ML (EQ 1MG BASE/ML) |
| HIKMA PHARMACEUTICALS USA INC | 077186 | AP (A-rated, therapeutically equivalent) | June 30, 2008 | EQ 4MG BASE/4ML (EQ 1MG BASE/ML) |
| DR REDDYS LABORATORIES LTD | 078846 | AB (A-rated, therapeutically equivalent) | February 27, 2009 | EQ 1MG BASE |
| SANDOZ INC | 078534 | AP (A-rated, therapeutically equivalent) | April 30, 2009 | EQ 0.1MG BASE/ML (EQ 0.1MG BASE/ML) |
| SANDOZ INC | 078531 | AP (A-rated, therapeutically equivalent) | April 30, 2009 | EQ 1MG BASE/ML (EQ 1MG BASE/ML), EQ 4MG BASE/4ML (EQ 1MG BASE/ML) |
| NATCO PHARMA LTD | 078969 | AB (A-rated, therapeutically equivalent) | June 22, 2009 | EQ 1MG BASE |
| RISING PHARMA HOLDINGS INC | 079078 | AP (A-rated, therapeutically equivalent) | September 14, 2009 | EQ 1MG BASE/ML (EQ 1MG BASE/ML), EQ 4MG BASE/4ML (EQ 1MG BASE/ML) |
| HIKMA FARMACEUTICA (PORTUGAL) SA | 078629 | AP (A-rated, therapeutically equivalent) | December 23, 2009 | EQ 1MG BASE/ML (EQ 1MG BASE/ML), EQ 4MG BASE/4ML (EQ 1MG BASE/ML) |
| MYLAN ASI LLC | 091136 | AP (A-rated, therapeutically equivalent) | April 9, 2010 | EQ 0.1MG BASE/ML (EQ 0.1MG BASE/ML), EQ 1MG BASE/ML (EQ 1MG BASE/ML) |
| MYLAN ASI LLC | 091137 | AP (A-rated, therapeutically equivalent) | April 9, 2010 | EQ 4MG BASE/4ML (EQ 1MG BASE/ML) |
| PHARMOBEDIENT CONSULTING LLC | 219282 | None (No TE code listed) | March 17, 2025 | EQ 2MG BASE/10ML |
Questions
Is there a generic for Kytril?
Yes. The generic name for Kytril is granisetron. 13 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB, AP. Generics match 5 of the 7 Kytril products the Orange Book lists.
What is the generic name for Kytril?
The active ingredient in Kytril is granisetron, 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.