FDA Orange Book · active-ingredient family
Triprolidine hydrochloride
Triprolidine hydrochloride is approved as 2 brand and 6 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.
Reference-listed drug:ACTIDIL · NDA 011496
2
Brand (NDA)
6
Generics (ANDA)
0
Listed patents
0
Exclusivity periods
Brand (NDA) products · syrup, tablet
Generic (ANDA) products (6)
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| TRIPROLIDINE HYDROCHLORIDE | HALSEY | ANDA 088735 | — | Jan 17, 1985 | |
| MYIDYL | USL PHARMA | ANDA 087963 | — | Jan 18, 1983 | |
| TRIPROLIDINE HYDROCHLORIDE | PHARM ASSOC | ANDA 087514 | — | Feb 10, 1982 | |
| TRIPROLIDINE HYDROCHLORIDE | ALPHARMA US PHARMS | ANDA 085940 | — | Approved Prior to Jan 1, 1982 | |
| TRIPROLIDINE HYDROCHLORIDE | VITARINE | ANDA 085610 | — | Approved Prior to Jan 1, 1982 | |
| TRIPROLIDINE HYDROCHLORIDE | WATSON LABS | ANDA 085094 | — | Approved Prior to Jan 1, 1982 |
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.
Triprolidine hydrochloride — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
