FDA Orange Book
Generic for Sovuna
Sovuna contains hydroxychloroquine. 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 Sovuna is hydroxychloroquine. 13 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB.
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Sovuna products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| tablet, oral | 200MG | Marketed (Rx) | None | 13 | AB |
| tablet, oral | 300MG | Marketed (Rx) | None | 2 | AB |
NDA 214581, held by NOVITIUM PHARMA LLC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Approved generic hydroxychloroquine
| Company | ANDA | TE code | Approved | Strengths |
|---|---|---|---|---|
| TEVA PHARMACEUTICALS USA | 040081 | AB (A-rated, therapeutically equivalent) | September 30, 1994 | 200MG |
| SANDOZ INC | 040104 | AB (A-rated, therapeutically equivalent) | November 30, 1995 | 200MG |
| CREEKWOOD PHARMACEUTICALS LLC | 040150 | AB (A-rated, therapeutically equivalent) | January 27, 1996 | 200MG |
| AUROBINDO PHARMA USA INC | 040274 | AB (A-rated, therapeutically equivalent) | May 29, 1998 | 200MG |
| IPCA LABORATORIES LTD | 040766 | AB (A-rated, therapeutically equivalent) | June 14, 2007 | 200MG |
| ZYDUS PHARMACEUTICALS USA INC | 040657 | AB (A-rated, therapeutically equivalent) | September 21, 2007 | 200MG |
| APPCO PHARMA LLC | 210441 | AB (A-rated, therapeutically equivalent) | May 1, 2018 | 200MG, 300MG |
| ALKALOIDA CHEMICAL CO ZRT | 201691 | AB (A-rated, therapeutically equivalent) | May 8, 2018 | 200MG |
| AMNEAL PHARMACEUTICALS CO GMBH | 210577 | AB (A-rated, therapeutically equivalent) | May 15, 2018 | 200MG |
| CHARTWELL RX SCIENCES LLC | 210543 | AB (A-rated, therapeutically equivalent) | July 6, 2018 | 200MG |
| LAURUS LABS LTD | 210959 | AB (A-rated, therapeutically equivalent) | January 15, 2019 | 200MG |
| ACCORD HEALTHCARE INC | 213342 | AB (A-rated, therapeutically equivalent) | April 7, 2020 | 200MG, 300MG |
| PHARMAZONE | 212902 | AB (A-rated, therapeutically equivalent) | May 14, 2020 | 200MG |
Sovuna NDC codes
Questions
Is there a generic for Sovuna?
Yes. The generic name for Sovuna is hydroxychloroquine. 13 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 Sovuna?
The active ingredient in Sovuna is hydroxychloroquine, 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.