Question 1

Is there a generic for Olive oil; soybean oil?

Accepted Answer

The FDA Orange Book does not currently list an approved generic (ANDA) for Olive oil; soybean oil. It is available as 1 brand (NDA) application.

Question 2

What is the reference-listed drug for Olive oil; soybean oil?

Accepted Answer

CLINOLIPID 20% (NDA 204508, BAXTER HLTHCARE CORP) is the reference-listed drug — the approved product a generic applicant must show its version is the same as.

Question 3

Does Olive oil; soybean oil have FDA marketing exclusivity?

Accepted Answer

Yes. The Orange Book records 1 marketing-exclusivity period for Olive oil; soybean oil. Exclusivity is granted by FDA at approval (for example new-chemical-entity, orphan-drug, or pediatric exclusivity) and runs independently of any listed patents.

Question 4

What dosage forms of Olive oil; soybean oil are approved?

Accepted Answer

Olive oil; soybean oil is approved in the following dosage form: emulsion.

Olive oil; soybean oil

Brand (NDA) products · emulsion

Marketing exclusivity (1)

Listed patents

Olive oil; soybean oil — frequently asked questions

Your Next Submission Could Take 6+ Fewer Weeks and Cost $250K Less.