FDA Orange Book

Generic for 8-mop

8-mop contains methoxsalen. 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 8-mop is methoxsalen. 1 company holds an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB.

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8-mop products in the Orange Book

8-mop products and approved generics
Form and routeStrengthBrand statusBrand TEActive genericsGeneric TE codes
capsule, oral10MGDiscontinuedNone1AB

NDA 009048, held by VALEANT PHARMACEUTICALS INTERNATIONAL. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.

Approved generic methoxsalen

Approved generic versions of 8-mop
CompanyANDATE codeApprovedStrengths
ONESOURCE SOFTGELS PTE LTD202687AB (A-rated, therapeutically equivalent)June 5, 201410MG

Questions

Is there a generic for 8-mop?

Yes. The generic name for 8-mop is methoxsalen. 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 8-mop?

The active ingredient in 8-mop is methoxsalen, 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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