What does “CRm” mean in the Orange Book context?
“CRm” isn’t a standard, commonly used label in the FDA’s Approved Drug Products with Therapeutic Equivalence Evaluations (the Orange Book). In practice, people often run into “CR” designations (related to changes/withdrawals in product listings) or “CR” categories tied to regulatory status, and the characters can be mistyped or auto-corrected in searches.
If you meant “CR” in the Orange Book, tell me the exact wording you see (or paste the line from the Orange Book), and I can explain what it means for that specific product.
Where do you see “CRm” on the Orange Book website?
To interpret it correctly, it helps to know where it appears:
- On the product listing (drug/strength/formulation)
- In the application/approval history
- In a drug name search result row
- In an export/download or dataset column
If you share:
1) the drug name you searched, and
2) the exact “CRm” text next to it (or the surrounding columns),
I can map it to the right Orange Book field.
How to find the right Orange Book entry for your drug
If you’re trying to locate the Orange Book record behind a particular “CRm” label, the fastest path is:
- Search the drug name on the Orange Book
- Open the specific NDA/ANDA listing for the product
- Check the fields shown on that row
If you tell me the active ingredient or brand name, I can point you to the corresponding Orange Book page/record structure to look for.
Is “CRM” ever used for something else that looks like Orange Book data?
Sometimes “CRm”/“CRM” shows up in other regulatory contexts (or in third-party spreadsheets that copy Orange Book data) and can reflect:
- internal tracking codes,
- dataset column names from a downloaded file,
- or a transcription artifact.
That’s why the exact text and the drug/row matter.
Want the exact meaning? Send one detail
Reply with either:
- the drug name you’re looking at, or
- the exact line/column where “CRm” appears,
and I’ll translate what that designation means in the Orange Book for that product.
Sources: None cited (your question didn’t provide a specific drug or the exact Orange Book text to interpret).