FDA Orange Book · active-ingredient family
Cyclopentolate hydrochloride
Cyclopentolate hydrochloride is approved in 13 FDA applications, with therapeutic-equivalence codes, listed patents, and marketing exclusivity from the FDA Orange Book.
0
Brand (NDA)
13
Generics (ANDA)
0
Listed patents
0
Exclusivity periods
Generic (ANDA) products (13)
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| CYCLOPENTOLATE HYDROCHLORIDE | SCIEGEN PHARMS | ANDA 205937 | — | Dec 09, 2015 | |
| AKPENTOLATE | RISING | ANDA 040164 | AT | Jan 13, 1997 | |
| AKPENTOLATE | RISING | ANDA 040165 | AT | Jan 13, 1997 | |
| PENTOLAIR | BAUSCH AND LOMB INC | ANDA 040075 | AT | Apr 29, 1994 | |
| CYCLOPENTOLATE HYDROCHLORIDE | ALCON PHARMS LTD | ANDA 089162 | — | Jan 24, 1991 | |
| PENTOLAIR | PHARMAFAIR | ANDA 088643 | — | Feb 09, 1987 | |
| PENTOLAIR | PHARMAFAIR | ANDA 088150 | — | Feb 25, 1983 | |
| AK-PENTOLATE | EPIC PHARMA LLC | ANDA 085555 | — | Approved Prior to Jan 1, 1982 | |
| CYCLOGYLRLD | ALCON LABS INC | ANDA 084109 | — | Approved Prior to Jan 1, 1982 | |
| CYCLOGYLRLD | ALCON LABS INC | ANDA 084110 | AT | Approved Prior to Jan 1, 1982 | |
| CYCLOGYLRLD | ALCON LABS INC | ANDA 084108 | AT | Approved Prior to Jan 1, 1982 | |
| CYCLOPENTOLATE HYDROCHLORIDE | SOLA BARNES HIND | ANDA 084150 | — | Approved Prior to Jan 1, 1982 | |
| CYCLOPENTOLATE HYDROCHLORIDE | SOLA BARNES HIND | ANDA 084863 | — | 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 — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
