FDA Orange Book
Generic for Prolixin Decanoate
Prolixin Decanoate contains fluphenazine decanoate. 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 Prolixin Decanoate is fluphenazine decanoate. 7 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AO.
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Prolixin Decanoate products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| injectable, injection | 25MG/ML | Discontinued | None | 7 | AO |
NDA 016727, held by BRISTOL MYERS SQUIBB CO. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Approved generic fluphenazine decanoate
| Company | ANDA | TE code | Approved | Strengths |
|---|---|---|---|---|
| FRESENIUS KABI USA LLC | 071413 | AO (A-rated, therapeutically equivalent) | July 14, 1987 | 25MG/ML |
| HIKMA PHARMACEUTICALS USA INC | 074531 | AO (A-rated, therapeutically equivalent) | August 30, 1996 | 25MG/ML |
| MYLAN LABORATORIES LTD | 075918 | AO (A-rated, therapeutically equivalent) | August 17, 2001 | 25MG/ML |
| PH HEALTH LTD | 203732 | AO (A-rated, therapeutically equivalent) | July 3, 2014 | 25MG/ML |
| EUGIA PHARMA SPECIALITIES LTD | 207739 | AO (A-rated, therapeutically equivalent) | October 17, 2017 | 25MG/ML |
| GLAND PHARMA LTD | 215509 | AO (A-rated, therapeutically equivalent) | March 30, 2023 | 25MG/ML |
| MSN LABORATORIES PRIVATE LTD | 215365 | AO (A-rated, therapeutically equivalent) | November 2, 2023 | 25MG/ML |
Questions
Is there a generic for Prolixin Decanoate?
Yes. The generic name for Prolixin Decanoate is fluphenazine decanoate. 7 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AO.
What is the generic name for Prolixin Decanoate?
The active ingredient in Prolixin Decanoate is fluphenazine decanoate, 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.