FDA Orange Book
Generic for Metrolotion
Metrolotion contains metronidazole. 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 Metrolotion is metronidazole. 1 company holds an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB.
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Metrolotion products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| lotion, topical | 0.75% | Marketed (Rx) | AB | 1 | AB |
NDA 020901, held by GALDERMA LABORATORIES LP. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Approved generic metronidazole
| Company | ANDA | TE code | Approved | Strengths |
|---|---|---|---|---|
| FOUGERA PHARMACEUTICALS INC | 077197 | AB (A-rated, therapeutically equivalent) | May 24, 2006 | 0.75% |
Metrolotion NDC codes
Questions
Is there a generic for Metrolotion?
Yes. The generic name for Metrolotion is metronidazole. 1 company holds an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB.
What is the generic name for Metrolotion?
The active ingredient in Metrolotion is metronidazole, 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.