FDA Orange Book
Generic for Delestrogen
Delestrogen contains estradiol valerate. 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 Delestrogen is estradiol valerate. 3 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AO.
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Delestrogen products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| injectable, injection | 10MG/ML | Marketed (Rx) | AO | 2 | AO |
| injectable, injection | 20MG/ML | Marketed (Rx) | AO | 3 | AO |
| injectable, injection | 40MG/ML | Discontinued | None | 3 | AO |
NDA 009402, held by PH HEALTH LTD. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Approved generic estradiol valerate
| Company | ANDA | TE code | Approved | Strengths |
|---|---|---|---|---|
| AMERICAN REGENT INC | 090920 | AO (A-rated, therapeutically equivalent) | January 19, 2010 | 20MG/ML, 40MG/ML |
| HIKMA FARMACEUTICA PORTUGAL SA | 203723 | AO (A-rated, therapeutically equivalent) | April 21, 2020 | 10MG/ML, 20MG/ML, 40MG/ML |
| XIROMED PHARMA ESPANA SL | 216656 | AO (A-rated, therapeutically equivalent) | April 28, 2023 | 10MG/ML, 20MG/ML, 40MG/ML |
Delestrogen NDC codes
Questions
Is there a generic for Delestrogen?
Yes. The generic name for Delestrogen is estradiol valerate. 3 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 Delestrogen?
The active ingredient in Delestrogen is estradiol valerate, 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.