FDA Orange Book
Generic for Vosol Hc
Vosol Hc contains acetic acid glacial and hydrocortisone. 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 Vosol Hc is acetic acid glacial and hydrocortisone. 2 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AT.
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Vosol Hc products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| solution/drops, otic | 2%;1% | Marketed (Rx) | AT | 2 | AT |
NDA 012770, held by SAPTALIS PHARMACEUTICALS LLC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Approved generic acetic acid glacial and hydrocortisone
| Company | ANDA | TE code | Approved | Strengths |
|---|---|---|---|---|
| TARO PHARMACEUTICAL INDUSTRIES LTD | 088759 | AT (A-rated, therapeutically equivalent) | March 4, 1985 | 2%;1% |
| COSETTE PHARMACEUTICALS NC LABORATORIES LLC | 040609 | AT (A-rated, therapeutically equivalent) | February 6, 2006 | 2%;1% |
Vosol Hc NDC codes
Questions
Is there a generic for Vosol Hc?
Yes. The generic name for Vosol Hc is acetic acid glacial and hydrocortisone. 2 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AT.
What is the generic name for Vosol Hc?
The active ingredient in Vosol Hc is acetic acid glacial and hydrocortisone, 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.