FDA Orange Book
Generic for Citanest Forte DENTAL
Citanest Forte DENTAL contains prilocaine and epinephrine. 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 Citanest Forte DENTAL is prilocaine and epinephrine. 1 company holds an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AP.
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Citanest Forte DENTAL products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| injectable, injection | 0.005MG/ML;4% | Marketed (Rx) | AP | 1 | AP |
NDA 021383, held by DENTSPLY PHARMACEUTICAL INC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Approved generic prilocaine and epinephrine
| Company | ANDA | TE code | Approved | Strengths |
|---|---|---|---|---|
| SEPTODONT INC | 078959 | AP (A-rated, therapeutically equivalent) | August 30, 2011 | 0.005MG/ML;4% |
Questions
Is there a generic for Citanest Forte DENTAL?
Yes. The generic name for Citanest Forte DENTAL is prilocaine and epinephrine. 1 company holds an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AP.
What is the generic name for Citanest Forte DENTAL?
The active ingredient in Citanest Forte DENTAL is prilocaine and epinephrine, 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.