FDA Orange Book · active-ingredient family
Cyclopentolate hydrochloride; phenylephrine hydrochloride
Cyclopentolate hydrochloride; phenylephrine hydrochloride is approved in 1 FDA application, with therapeutic-equivalence codes, listed patents, and marketing exclusivity from the FDA Orange Book.
0
Brand (NDA)
1
Generics (ANDA)
0
Listed patents
0
Exclusivity periods
Generic (ANDA) products (1)
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| CYCLOMYDRILRLD | ALCON LABS INC | ANDA 084300 | — | 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.
Cyclopentolate hydrochloride; phenylephrine hydrochloride — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
