# FDA Purple Book — licensed biologics + biosimilars (silver)

`drug_silver.dim_purple_book_product` · Drugs and formularies · status partial

The promoted silver Purple Book: FDA licensed biological products with license_type (351(a) reference biologic vs 351(k) biosimilar / interchangeable), reference-product linkage, and exclusivity dates. The biosimilar-substitution lens behind the biosimilar_window MCP tool.

**Grain.** One row per (bla_number, product_number) per snapshot.

| column | type | meaning |
|---|---|---|
| bla_number | string |  |
| product_number | string |  |
| applicant | string |  |
| proprietary_name | string |  |
| proper_name | string |  |
| license_type | string | 351(a) original biologic, 351(k) Biosimilar / 351(k) Interchangeable |
| strength | string |  |
| dosage_form | string |  |
| route_of_administration | string |  |
| product_presentation | string |  |
| marketing_status | string |  |
| licensure_status | string |  |
| approval_date | date |  |
| ref_product_proper_name | string |  |
| ref_product_proprietary_name | string |  |
| submission_type | string |  |
| license_number | string |  |
| center | string |  |
| date_of_first_licensure | date |  |
| exclusivity_expiration_date | date |  |
| ref_product_exclusivity_exp_date | date |  |
| orphan_exclusivity_exp_date | date |  |
| patent_list_provided | string |  |
| observed_period | date |  |
| asserted_at | date |  |
| effective_period_start | date |  |
| effective_period_end | date |  |
| cms_vintage_sequence | int |  |
| parse_revision | int |  |
| parser_artifact_hash | string |  |
| source_url | string |  |
| sha256_content_hash | string |  |
| source_id | string |  |
| is_current | boolean |  |
| bronze_object_key | string |  |
| s3_version_id | string |  |
| vintage_tag | string |  |
| drug_source_version_id | string |  |

Query it: `query_substrate` with `SELECT ... FROM drug_silver.dim_purple_book_product WHERE ... LIMIT 100`; read `describe_data_source("drug_silver.dim_purple_book_product")` first.