FDA Orange Book
Generic for Loprox
Loprox contains ciclopirox. 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 Loprox is ciclopirox. 8 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB, AT.
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Loprox products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| cream, topical | 0.77% | Marketed (Rx) | AB | 5 | AB |
| shampoo, topical | 1% | Discontinued | None | 5 | AT |
| suspension, topical | 0.77% | Marketed (Rx) | AB | 2 | AB |
NDA 018748, 021159, 019824, held by EUROFARMA INC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Approved generic ciclopirox
| Company | ANDA | TE code | Approved | Strengths |
|---|---|---|---|---|
| FOUGERA PHARMACEUTICALS INC | 076422 | AB (A-rated, therapeutically equivalent) | August 6, 2004 | 0.77% |
| FOUGERA PHARMACEUTICALS INC | 076435 | AB (A-rated, therapeutically equivalent) | December 29, 2004 | 0.77% |
| SUN PHARMA CANADA INC | 076790 | AB (A-rated, therapeutically equivalent) | April 12, 2005 | 0.77% |
| PADAGIS ISRAEL PHARMACEUTICALS LTD | 077364 | AB (A-rated, therapeutically equivalent) | March 3, 2006 | 0.77% |
| PADAGIS ISRAEL PHARMACEUTICALS LTD | 077676 | AB (A-rated, therapeutically equivalent) | December 15, 2006 | 0.77% |
| GLENMARK PHARMACEUTICALS INC USA | 090273 | AB (A-rated, therapeutically equivalent) | November 10, 2009 | 0.77% |
| ACTAVIS MID ATLANTIC LLC | 090490 | AT (A-rated, therapeutically equivalent) | November 24, 2009 | 1% |
| PADAGIS US LLC | 078594 | AT (A-rated, therapeutically equivalent) | February 16, 2010 | 1% |
| FOUGERA PHARMACEUTICALS INC | 090146 | AT (A-rated, therapeutically equivalent) | May 25, 2010 | 1% |
| COSETTE PHARMACEUTICALS NC LABORATORIES LLC | 078463 | AB (A-rated, therapeutically equivalent) | December 20, 2010 | 0.77% |
| SUN PHARMA CANADA INC | 090269 | AT (A-rated, therapeutically equivalent) | February 23, 2011 | 1% |
| ENCUBE ETHICALS PRIVATE LTD | 209975 | AT (A-rated, therapeutically equivalent) | April 5, 2018 | 1% |
Questions
Is there a generic for Loprox?
Yes. The generic name for Loprox is ciclopirox. 8 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB, AT.
What is the generic name for Loprox?
The active ingredient in Loprox is ciclopirox, 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.