Actifed W/ Codeine
Codeine Phosphate; Pseudoephedrine Hydrochloride; Triprolidine Hydrochloride
Sourced from the FDA Orange Book
Key dates
Key dates
Approval
FDA approval date of this drug product.
Apr 04, 1984
42 yr 11 mo ago
Today
Pharmaceutical detail
Pharmaceutical detail
Active ingredient
CODEINE PHOSPHATE; PSEUDOEPHEDRINE HYDROCHLORIDE; TRIPROLIDINE HYDROCHLORIDE
Strength
10MG/5ML;30MG/5ML;1.25MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Dosage form
SYRUP
Route
ORAL
TE code
Not listed
Application
NDA 012575
Product number
003
Marketing status
Discontinued
Reference listed drug (RLD)
No
Reference standard (RS)
No
Active-ingredient family
This is a brand (NDA) product. Other products sharing this active ingredient are listed below.
- 1986Triprolidine And Pseudoephedrine Hydrochlorides W/ CodeineGeneric (ANDA)
ANDA 089018 · Cenci
- 1985Triacin-cGeneric (ANDA)
ANDA 088704 · Anima
- 1984Triprolidine Hydrochloride, Pseudoephedrine Hydrochloride And Codeine PhosphateGeneric (ANDA)
ANDA 088833 · Wockhardt
Listed 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.
Actifed W/ Codeine — 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 Codeine Phosphate; Pseudoephedrine Hydrochloride; Triprolidine Hydrochloride 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.
