FDA Orange Book

Is there a generic for Clinolipid?

Clinolipid contains olive oil and soybean oil. 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

No. The Orange Book lists no active FDA-approved generic (ANDA) for Clinolipid (olive oil and soybean oil). The Orange Book shows its last listed exclusivity ends April 24, 2027.

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Clinolipid products in the Orange Book

Clinolipid products and approved generics
Form and routeStrengthBrand statusBrand TEActive genericsGeneric TE codes
emulsion, intravenous16%(160GM/1000ML);4% (40GM/1000ML)Marketed (Rx)None0None

NDA 204508, held by BAXTER HEALTHCARE CORP. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.

Clinolipid exclusivity

Exclusivity listed for Clinolipid
CodeMeaningExpiresNDA
NPPNew patient populationApril 24, 2027204508

Clinolipid NDC codes

Questions

Is there a generic for Clinolipid?

No. The Orange Book lists no active FDA-approved generic (ANDA) for Clinolipid (olive oil and soybean oil). The Orange Book shows its last listed exclusivity ends April 24, 2027.

What is the generic name for Clinolipid?

The active ingredient in Clinolipid is olive oil and soybean oil, 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.

More on Clinolipid and Olive Oil and Soybean Oil

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