Baycol
Cerivastatin Sodium
Sourced from the FDA Orange Book
Key dates
Key dates
Approval
FDA approval date of this drug product.
Jun 26, 1997
29 yr 6 mo ago
Today
Pharmaceutical detail
Pharmaceutical detail
Active ingredient
CERIVASTATIN SODIUM
Strength
0.1MG
Dosage form
TABLET
Route
ORAL
TE code
Not listed
Application
NDA 020740
Product number
002
Marketing status
Discontinued
Reference listed drug (RLD)
No
Reference standard (RS)
No
Other strengths in NDA 020740
Active-ingredient family
This is a brand (NDA) product. Other products sharing this active ingredient are listed below.
No other applications share this active ingredient.
View full Cerivastatin Sodium familyListed patents
Listed patents
No patents are listed against this product in the Orange Book. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.
Baycol — frequently asked questions
Approval, therapeutic equivalence, patents, and exclusivity for this product, from the FDA Orange Book.
Built directly from the FDA Orange Book data file. This product page links back to the Cerivastatin Sodium active-ingredient family, which is the canonical reference for generics, patents, and exclusivity across all strengths.
Related FDA reference tools
- FDA Purple BookLicensed biologics, biosimilars, interchangeables, BLA records, and exclusivity dates.
- FDA BiosimilarsThe list of FDA-approved biosimilars and interchangeable biosimilars, by reference product.
- 510(k) Predicate DatabaseSearch FDA 510(k) clearances and map predicate-device lineage.
- FDA 483 & Inspection DatabaseFDA Form 483 observations and inspection records by firm, date, and citation.
