FDA Orange Book
Generic for Spectazole
Spectazole contains econazole nitrate. 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 Spectazole is econazole nitrate. 4 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB.
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Spectazole products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| cream, topical | 1% | Discontinued | None | 4 | AB |
NDA 018751, held by ALVOGEN INC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Approved generic econazole nitrate
| Company | ANDA | TE code | Approved | Strengths |
|---|---|---|---|---|
| SUN PHARMA CANADA INC | 076005 | AB (A-rated, therapeutically equivalent) | November 26, 2002 | 1% |
| PADAGIS ISRAEL PHARMACEUTICALS LTD | 076479 | AB (A-rated, therapeutically equivalent) | June 23, 2004 | 1% |
| ENCUBE ETHICALS PRIVATE LTD | 076574 | AB (A-rated, therapeutically equivalent) | December 17, 2004 | 1% |
| AUROBINDO PHARMA USA INC | 210364 | AB (A-rated, therapeutically equivalent) | April 18, 2018 | 1% |
Questions
Is there a generic for Spectazole?
Yes. The generic name for Spectazole is econazole nitrate. 4 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB.
What is the generic name for Spectazole?
The active ingredient in Spectazole is econazole nitrate, 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.