FDA Orange Book
Generic for Clindagel
Clindagel contains clindamycin. 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 Clindagel is clindamycin. 11 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB1, AB2.
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Clindagel products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| gel, topical | EQ 1% BASE | Marketed (Rx) | AB2 | 11 | AB1, AB2 |
NDA 050782, 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
| Company | ANDA | TE code | Approved | Strengths |
|---|---|---|---|---|
| FOUGERA PHARMACEUTICALS INC | 064160 | AB1 (A-rated, therapeutically equivalent) | January 28, 2000 | EQ 1% BASE |
| AMVIKA PHARMA LLC | 211872 | AB1 (A-rated, therapeutically equivalent) | July 29, 2020 | EQ 1% BASE |
| SUN PHARMA CANADA INC | 214052 | AB1 (A-rated, therapeutically equivalent) | November 10, 2020 | EQ 1% BASE |
| PADAGIS ISRAEL PHARMACEUTICALS LTD | 212104 | AB1 (A-rated, therapeutically equivalent) | December 31, 2020 | EQ 1% BASE |
| GLENMARK PHARMACEUTICALS LTD | 214251 | AB1 (A-rated, therapeutically equivalent) | February 10, 2021 | EQ 1% BASE |
| ENCUBE ETHICALS PRIVATE LTD | 212438 | AB1 (A-rated, therapeutically equivalent) | March 11, 2021 | EQ 1% BASE |
| SOLARIS PHARMA CORP | 212842 | AB2 (A-rated, therapeutically equivalent) | August 13, 2021 | EQ 1% BASE |
| AMNEAL PHARMACEUTICALS LLC | 214668 | AB2 (A-rated, therapeutically equivalent) | August 5, 2022 | EQ 1% BASE |
| ZYDUS LIFESCIENCES LTD | 216587 | AB1 (A-rated, therapeutically equivalent) | September 19, 2023 | EQ 1% BASE |
| ALEMBIC PHARMACEUTICALS LTD | 212466 | AB1 (A-rated, therapeutically equivalent) | April 2, 2024 | EQ 1% BASE |
| AUROBINDO PHARMA LTD | 218942 | AB1 (A-rated, therapeutically equivalent) | March 18, 2026 | EQ 1% BASE |
Clindagel NDC codes
Questions
Is there a generic for Clindagel?
Yes. The generic name for Clindagel is clindamycin. 11 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 Clindagel?
The active ingredient in Clindagel is clindamycin, 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.
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