FDA Orange Book
Generic for Ziana
Ziana contains clindamycin and tretinoin. 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 Ziana is clindamycin and tretinoin. 3 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB1, AB2.
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Ziana products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| gel, topical | 1.2%;0.025% | Marketed (Rx) | AB1 | 3 | AB1, AB2 |
NDA 050802, held by BAUSCH HEALTH US LLC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Approved generic clindamycin and tretinoin
| Company | ANDA | TE code | Approved | Strengths |
|---|---|---|---|---|
| ACTAVIS MID ATLANTIC LLC | 202564 | AB1 (A-rated, therapeutically equivalent) | June 12, 2015 | 1.2%;0.025% |
| SOLARIS PHARMA CORP | 212845 | AB2 (A-rated, therapeutically equivalent) | February 10, 2022 | 1.2%;0.025% |
| ENCUBE ETHICALS PRIVATE LTD | 216943 | AB2 (A-rated, therapeutically equivalent) | September 1, 2023 | 1.2%;0.025% |
Ziana NDC codes
Questions
Is there a generic for Ziana?
Yes. The generic name for Ziana is clindamycin and tretinoin. 3 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB1, AB2.
What is the generic name for Ziana?
The active ingredient in Ziana is clindamycin and tretinoin, 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.